Systems and devices for filtering biological products and methods of using the same are provided. A filtration system can include a filtration skid configured to be adapted for engagement with components of a single-use assembly for facilitating one or more unit operations of a continuous filtering process for the one or more biological products. The filtration skid can include a pump cart and a filtration cart. The filtration cart can include a first filter support assembly configured to support a first filtering flow channel and a second filter support assembly configured to support a second filtering flow channel.
The present disclosure provides methods and compositions for improving the in vitro transcription (IVT) of messenger RNA using Klebsiella phage KP34 RNA polymerase. In particular, the present disclosure provides a method for manufacturing messenger RNA comprising: (a) providing a DNA template comprising a nucleic acid sequence encoding an mRNA transcript for expression of a polypeptide or protein; (b) contacting the DNA template with a Klebsiella phage KP34 RNA polymerase under conditions suitable for IVT of the mRNA transcript.
This invention relates to compositions (e.g. immunogenic compositions) which can be used to immunise against C. acnes. The compositions comprise C. acnes antigens and antigen combinations, used in the form of nucleic acids (e.g. mRNAs) encoding antigenic proteins or in the form of recombinant protein antigens.
A61K 39/145 - Orthomyxoviridae, e.g. influenza virus
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 9/1272 - Non-conventional liposomes, e.g. PEGylated liposomes or liposomes coated or grafted with polymers comprising non-phosphatidyl surfactants as bilayer-forming substances, e.g. cationic lipids or non-phosphatidyl liposomes coated or grafted with polymers
A61K 31/7105 - Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
A61K 39/00 - Medicinal preparations containing antigens or antibodies
A61P 31/16 - Antivirals for RNA viruses for influenza or rhinoviruses
The present invention provides, in part, dianhydrohexitol-based cationic lipids of Formula (I), and sub-formulas thereof:
The present invention provides, in part, dianhydrohexitol-based cationic lipids of Formula (I), and sub-formulas thereof:
or a pharmaceutically acceptable saft thereof. The present invention also provides, in part, dianhydrohexitol-based cationic lipids of Formula (II), and sub-formulas thereof:
The present invention provides, in part, dianhydrohexitol-based cationic lipids of Formula (I), and sub-formulas thereof:
or a pharmaceutically acceptable saft thereof. The present invention also provides, in part, dianhydrohexitol-based cationic lipids of Formula (II), and sub-formulas thereof:
or a pharmaceutically acceptable salt thereof. The compounds provided herein be useful for delivery and expression of mRNA and encoded protein, e.g., as a component of liposomal delivery vehicle, and accordingly can be useful for treating various diseases, disorders and conditions, such as those associated with deficiency of one or more proteins.
A61K 31/7105 - Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
Provided are mixed carrier, multivalent pneumococcal conjugate compositions comprising 21 different pneumococcal capsular polysaccharide-protein conjugates, wherein each of the conjugates includes a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to either tetanus toxoid (TT) or CRM197, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F, where the capsular polysaccharides of two of serotypes 1, 3, and 5 and one or both of serotypes 15B and 22F are conjugated to TT and the remaining capsular polysaccharides are conjugated to CRM197. Also provided are methods of producing the mixed carrier, multivalent pneumococcal conjugate compositions and methods of using the same for prophylaxis against Streptococcus pneumoniae infection or disease in a subject.
The present invention relates to a method for tailing in vitro transcribed (IVT) messenger RNA (mRNA) comprising a modified ribonucleotide, said method comprising adding the IVT mRNA to a tailing polymerase in a reaction buffer comprising 30 mM or less of an alkali metal salt and 5 mM or more of a reducing agent.
The present invention provides, in part, bis-ester and amide cationic lipid compounds of Formula (I): or a pharmaceutically acceptable salt thereof, bis-ester and amide cationic lipid compounds of Formula (II): or a pharmaceutically acceptable salt thereof, bis-ester and amide cationic lipid compounds of Formula (III): or a pharmaceutically acceptable salt thereof, and bis-ester and amide cationic lipid compounds of Formula (IV): or a pharmaceutically acceptable salt thereof. The compounds provided herein can be useful for delivery and expression of mRNA and encoded protein, e.g., as a component of liposomal delivery vehicle, and accordingly can be useful for treating various diseases, disorders and conditions, such as those associated with deficiency of one or more proteins.
The present invention provides, in part, bis-ester and amide cationic lipid compounds of Formula (I): or a pharmaceutically acceptable salt thereof, bis-ester and amide cationic lipid compounds of Formula (II): or a pharmaceutically acceptable salt thereof, bis-ester and amide cationic lipid compounds of Formula (III): or a pharmaceutically acceptable salt thereof, and bis-ester and amide cationic lipid compounds of Formula (IV): or a pharmaceutically acceptable salt thereof. The compounds provided herein can be useful for delivery and expression of mRNA and encoded protein, e.g., as a component of liposomal delivery vehicle, and accordingly can be useful for treating various diseases, disorders and conditions, such as those associated with deficiency of one or more proteins.
A61K 48/00 - Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseasesGene therapy
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
C07C 229/22 - Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated the carbon skeleton being further substituted by oxygen atoms
A61K 9/1272 - Non-conventional liposomes, e.g. PEGylated liposomes or liposomes coated or grafted with polymers comprising non-phosphatidyl surfactants as bilayer-forming substances, e.g. cationic lipids or non-phosphatidyl liposomes coated or grafted with polymers
A61K 39/00 - Medicinal preparations containing antigens or antibodies
The present disclosure provides multivalent influenza vaccine compositions comprising at least three messenger RNAs (mRNAs) encoding a combination of influenza A and influenza B hemagglutinin (HA) antigens, wherein the mRNA encoding the HA antigen of the influenza A virus is present in a different ratio (w/w) than the mRNA encoding the influenza B virus, and methods of eliciting an immune response by administering said compositions. In particular, the disclosures relate to mRNA encoding these antigens formulated in a lipid nanoparticle (LNP).
A61K 39/00 - Medicinal preparations containing antigens or antibodies
A61K 47/28 - Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
Provided herein is a fusion protein comprising a messenger RNA (mRNA) capping enzyme polypeptide linked to a Fh8 polypeptide or fragment thereof. Also provided are methods of preparing a mRNA comprising the step of capping using the capping enzymes described herein.
Systems and methods can apply machine learning techniques to predict biological responses. One of the methods is performed by at least one processor executing executable logic including at least one machine learning model trained to predict biological responses. The method includes receiving first sequence data of a first molecular sequence, receiving second sequence data of a second molecular sequence, and predicting a biological response for the second molecular sequence based at least partly on the received first and second sequence data.
G16B 40/00 - ICT specially adapted for biostatisticsICT specially adapted for bioinformatics-related machine learning or data mining, e.g. knowledge discovery or pattern finding
Provided herein are lipid nanoparticles (LNPs) comprising an ionizable or cationic lipid, a helper lipid, a structural lipid, and a stealth lipid. The LNPs provided herein can be useful for delivery and expression of mRNA and encoded protein and accordingly can be useful for treating various diseases, disorders and conditions, such as those associated with deficiency of one or more proteins.
A61K 31/7105 - Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
C12N 15/88 - Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation using microencapsulation, e.g. using liposome vesicle
15.
DIANHYDROHEXITOL BASED IONIZABLE LIPIDS FOR NUCLEIC ACID DELIVERY
e.g.e.g., as a component of liposomal delivery vehicle, and accordingly can be useful for treating various diseases, disorders and conditions, such as those associated with deficiency of one or more proteins.
A61K 31/34 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
According to the present disclosure, there is provided an intranasal medicament delivery system comprising a pump dispenser, a medicament container having a central axis, an intranasal nozzle and a connector. The intranasal nozzle comprises first and second nozzle outlets for delivering medicament to a user. The connector is configured to couple the pump dispenser to the medicament container such that the pump dispenser extends from the connector at an angle in the range of about 70 to 110 degrees relative to the central axis of the medicament container. According to the present disclosure, there is also provided a method of preparing an intranasal medicament delivery system.
An adapter for an intranasal nozzle, the adapter having an external surface for resting against a user's nostril and an aperture that extends from a first opening at a first end of the adapter to a second opening at a second end of the adapter. The aperture is configured to receive a conduit of the intranasal nozzle for fixing the adapter to the conduit. Different adapters can be fitted with the same intranasal nozzle to adapt the intranasal nozzle to different users.
According to the present disclosure, there is provided an intranasal medicament delivery device comprising a housing for receiving a medicament container, wherein the medicament container comprises a sealing element. The intranasal medicament delivery device further comprises an intranasal nozzle, a needle configured to fluidly communicate with the medicament container, and an actuator. The actuator is configured such that, when a medicament container is received in the housing, the actuator is operable by a user to move the medicament container from a first position, wherein the medicament container is sealed by the sealing element, to a second position, wherein the needle punctures the sealing element to fluidly communicate with the medicament container. According to the present disclosure there is also provided an intranasal medicament delivery system and a method of operating an intranasal medicament delivery system.
According to the present disclosure, there is provided an intranasal nozzle comprising first and second medicament delivery conduits for fluidly communicating with a fluid flow generator such that, in use, the fluid flow generator is operable to expel medicament from the first and second medicament delivery conduits for delivery to a user. The intranasal nozzle comprises a flexible portion configured to allow for the position of at least one of the first and second medicament delivery conduits to be adjusted. The present disclosure also relates to an intranasal medicament delivery system and to a method of preparing an intranasal medicament delivery system.
According to the present disclosure, there is provided an intranasal medicament delivery system comprising: an intranasal nozzle; and an adapter for a medicament vial, the adapter comprising: a coupling for connecting to the medicament vial; an inlet; and a first channel and a second channel configured to respectively receive a first conduit and a second conduit of the intranasal nozzle, wherein the first channel and the second channel are arranged such that, in use, when the coupling is connected to the medicament vial and the first conduit and the second conduit of the intranasal nozzle are respectively received in the first channel and the second channel, a medicament contained in the medicament vial can be drawn through the inlet into the first conduit and the second conduit via the first channel and the second channel respectively.
The present disclosure relates to a medicament delivery device comprising a housing, a plunger, and an actuator moveable relative to the housing to urge the plunger to move in a first direction relative to the housing. The device comprises a drive mechanism configured such that, in use, the drive mechanism is operable to move the plunger in a second direction to expel medicament from the device. The device comprises a trigger configured such that, prior to movement of the actuator relative to the housing the trigger is prevented from being actuated to operate the drive mechanism, and such that once the actuator has been moved relative to the housing the trigger is permitted to be actuated by a user to operate the drive mechanism. The present disclosure also relates to a medicament delivery system and to a method of preparing a medicament delivery system.
According to the present disclosure, there is provided an intranasal nozzle (200') for an intranasal medicament delivery device (100, 100'). The intranasal nozzle comprises first and second nozzle outlets (203', 204'), a seal (128), and a valve member (130). The seal (128) is configured to seal against the intranasal medicament delivery device (100, 100'). The valve member (130) is configured such that, when the seal (128) is sealed against the intranasal medicament delivery device, the valve member (130) inhibits the ingress of air into an outlet (1213) of the intranasal medicament delivery device via the intranasal nozzle (200') and wherein, in use, the intranasal medicament delivery device (100, 100') is operable to expel medicament from the outlet (1213) and through the first and second nozzle outlets (203', 204') for delivery to a user. The present disclosure also relates to an intranasal medicament delivery system (1, 1'), a kit of parts for an intranasal medicament delivery system, and a method (2000) of preparing an intranasal medicament delivery system.
The present disclosure relates to a medicament delivery device comprising a housing and a plunger within the housing and configured such that, in use, the plunger is moveable relative to the housing in a first direction and a second direction. The medicament delivery device comprises a drive biasing member and an actuator. The drive biasing member is configured to exert a force on the plunger to urge the plunger in the second direction such that, in use, medicament is expelled from the medicament delivery device for delivery to a user. The actuator is configured to be moved relative to the housing to urge the plunger relative to the housing in the first direction against the force of the drive biasing member. The present disclosure also relates to a medicament delivery system and to a method of preparing a medicament delivery system.
The present disclosure relates to a medicament delivery device comprising a housing, a chamber for receiving medicament from a container of medicament, and a drive mechanism. The medicament delivery device further comprises a plunger within the housing and configured such that, in use, the plunger is moveable relative to the housing in a first direction from a first position to an second position to draw medicament into the chamber from the container and is moveable relative to the housing in a second direction from the second position to a primed position to expel a priming volume of the medicament from the chamber. The drive mechanism is configured such that, in use, the drive mechanism is operable to move the plunger from the primed position in the second direction to expel a dosage volume of the medicament from the chamber for delivery to a user. The present disclosure also relates to a medicament delivery system and to a method of preparing a medicament delivery system.
A medicament delivery system The present disclosure relates to an intranasal medicament delivery system (1, l1, 1"). The intranasal medicament delivery system comprises a housing (110), a plunger (124) within the housing, a drive mechanism (124s), and an intranasal nozzle (200', 200") through which medicament can be expelled for delivery to a user. A portion (210) of the intranasal medicament delivery system is configured to be pressed against the user's body to move relative to the housing from a first position to a second position to operate the drive mechanism such that, in use, the drive mechanism urges the plunger (124) to move relative to the housing to expel medicament from the system via the intranasal nozzle. The present disclosure also relates to an intranasal medicament delivery system and to a method of operating an intranasal medicament delivery system.
The present disclosure relates to an intranasal nozzle for medicament delivery. The intranasal nozzle comprises first and second delivery members. The first delivery member is configured to be inserted into a first nostril of a patient and comprises a first end portion that has a first medicament outlet. The second delivery member is configured to be inserted into a second nostril of the patient and comprises a second end portion that has a second medicament outlet. A gap is disposed between the first and second delivery members that is configured to receive at least a portion of the septum of the patient's nose when the first and second delivery members are inserted into the first and second nostrils. The width of the gap between the end portions of the first and second delivery members is at least 6 mm and the external width of the intranasal nozzle at the end portions is at most 20 mm. The present disclosure also relates to an intranasal medicament delivery system and to a method of delivering medicament to a patient.
According to the present disclosure, there is provided an intranasal nozzle comprising a coupling for connecting to a fluid flow generator and comprising an inlet. The intranasal nozzle further comprises a medicament reservoir for containing a medicament and first and second nozzle outlets. The intranasal nozzle further comprises a sealing member configured to seal the inlet prior to connection of the fluid flow generator to the coupling. The sealing member is configured such that, in use, when the fluid flow generator is connected to the coupling, the fluid flow generator is operable to generate a fluid flow that enters the inlet to expel medicament from the first and second nozzle outlets for delivery to a user. The present disclosure also relates to an intranasal nozzle for a medicament delivery device, the medicament delivery device comprising a piston that is moveable to dispense fluid from a container. The intranasal nozzle comprises first and second medicament delivery outlets and a coupling configured to couple to a medicament delivery device. The intranasal nozzle is configured such that, in use, when the intranasal nozzle is connected to the medicament delivery device, the medicament delivery device is operable to move the piston relative to the container to generate a fluid flow that enters the intranasal nozzle such that medicament is expelled from the first and second medicament delivery outlets for delivery to a user. The present disclosure also relates to a method of preparing an intranasal medicament delivery system.
According to the present disclosure, there is provided a medicament delivery device comprising a housing for receiving a medicament container, wherein the medicament container comprises a sealing element. The medicament delivery device comprises a needle for fluidly communicating with the medicament container and a cap that comprises a flexible wall comprising a sealing portion and a gripping portion. The cap is configured such that, when a medicament container is received in the housing, the medicament container is moveable relative to the housing to cause the cap to be deformed from an initial position, wherein the cap seals an end of the needle, to a deformed position, wherein the end of the needle penetrates the cap and the sealing element of the medicament container. Movement of the cap from the initial position to the deformed position causes the sealing portion of the cap to seal against the medicament container and the gripping portion to move inwardly to grip the needle. According to the present disclosure, there is also provided a medicament delivery system and a method of preparing a medicament delivery system.
The present disclosure relates to an intranasal nozzle for a medicament delivery system. The intranasal nozzle comprises first and second nozzle outlets and at least one capillary channel. The at least one capillary channel comprises a channel inlet for communicating with a reservoir of medicament such that, in use, the capillary channel is suppliable with medicament from the reservoir. The at least one capillary channel comprises a channel outlet configured such that, in use, medicament in the capillary channel is expellable from the channel outlet for delivery to a user. The present disclosure also relates to an intranasal nozzle for fluidly communicating with a fluid flow generator, wherein the intranasal nozzle comprises first and second nozzle outlets. Each nozzle outlet comprises a valve moveable from a closed state, to prevent the ingress of air into the intranasal nozzle via the respective nozzle outlet, to an open state, to permit medicament supplied from a medicament reservoir to be expelled from the respective nozzle outlet for delivery to a user. Each valve is configured to move from the closed state to the open state upon operation of the fluid flow generator. The present disclosure also relates to an intranasal medicament delivery system, a kit of parts for an intranasal medicament delivery system, and to a method of preparing an intranasal medicament delivery system.
According to the present disclosure, there is provided an intranasal medicament delivery system comprising: a first part comprising an outlet fluidly communicated with a medicament reservoir for containing a medicament; and, a second part comprising a sealing portion, an inlet and a fluid delivery path that is fluidly communicated with the inlet. The second part is configured to be moved relative to the first part from a sealing state, wherein the sealing portion seals the outlet of the first part to prevent the egress of medicament from the outlet, to a delivery state, wherein the inlet is fluidly connected to the outlet of the first part such that, in use, medicament can be expelled from the medicament reservoir and along the fluid delivery path for delivery to a user. The present disclosure also relates to a method of preparing an intranasal medicament delivery system.
Aspects of the disclosure relate to an intranasal medicament delivery device. The device comprises: first and second outlets for delivering medicament intranasally to a user; a chamber for fluidly communicating with a medicament container; and a plunger. The plunger is configured such that, in use when a medicament container is fluidly communicated with the chamber, the plunger is moveable in a first direction relative to the chamber to draw medicament from the medicament container and into the chamber, and is moveable in a second direction relative to the chamber to cause medicament in the chamber to be expelled from the chamber and out of the first and second outlets. The device comprises a first valve configured to move between a first state, wherein fluid flow into the chamber via the first and second outlets is prevented whilst the plunger is moved in the first direction to draw medicament from the medicament container and into the chamber, and a second state, wherein movement of the plunger in the second direction expels medicament from the chamber and out of the first and second outlets. The present disclosure also relates to a method of preparing an intranasal medicament delivery system.
The present disclosure relates to a medicament delivery device. The medicament delivery device comprises a housing comprising an inlet port configured to interface with a medicament container. The medicament delivery device comprises a chamber for receiving medicament from the medicament container and a plunger configured such that, in use, when a medicament container is interfaced with the inlet port, the plunger can be moved in a first direction to draw medicament from the medicament container and into the chamber. The medicament delivery device also comprises a drive mechanism operable to urge the plunger in a second direction to expel the medicament from the chamber for delivery to a user. The present disclosure also relates to a medicament delivery system, a kit of parts for a medicament delivery system, and a method of preparing a medicament delivery system.
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests
A61M 5/24 - Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
According to the present disclosure, there is provided an intranasal nozzle comprising: a coupling for connecting to a fluid flow generator and comprising an inlet; a body having a passage; a first medicament delivery conduit in fluid communication with the passage; a second medicament delivery conduit in fluid communication with the passage; and a rupturable balloon for containing a medicament, wherein the balloon is held within the passage such that, in use, the balloon is rupturable to release the medicament from the balloon for delivery to a subject through the first medicament delivery conduit and the second medicament delivery conduit.
The present invention provides lipids of Formula (I) and (II) or subformulae thereof, or pharmaceutically acceptable salts thereof. Said lipids can be useful for the delivery and expression of mRNA and encoded protein, e.g. as a component of liposomal delivery vehicles, and accordingly can be useful for treating various diseases, disorders, and conditions, such as those associated with deficiency of one or more proteins. Compositions comprising lipid compounds of Formulae (I) and (II) and subformulae thereof, and mRNA encoding a peptide or protein may be administered to subjects in need thereof intramuscularly.
A61K 9/127 - Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
C07C 329/06 - Esters of monothiocarbonic acids having sulfur atoms of thiocarbonic groups bound to acyclic carbon atoms
C07C 327/30 - Esters of monothiocarboxylic acids having sulfur atoms of esterified thiocarboxyl groups bound to carbon atoms of hydrocarbon radicals substituted by nitrogen atoms, not being part of nitro or nitroso groups
C07C 323/25 - Thiols, sulfides, hydropolysulfides or polysulfides substituted by halogen, oxygen or nitrogen atoms, or by sulfur atoms not being part of thio groups containing thio groups and nitrogen atoms, not being part of nitro or nitroso groups, bound to the same carbon skeleton having the sulfur atoms of the thio groups bound to acyclic carbon atoms of the carbon skeleton the carbon skeleton being acyclic and saturated
C07C 229/16 - Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having only one amino and one carboxyl group bound to the carbon skeleton the nitrogen atom of the amino group being further bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings to carbon atoms of hydrocarbon radicals substituted by amino or carboxyl groups, e.g. ethylenediamine-tetra-acetic acid, iminodiacetic acids
C07C 229/12 - Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having only one amino and one carboxyl group bound to the carbon skeleton the nitrogen atom of the amino group being further bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings to carbon atoms of acyclic carbon skeletons
C07C 219/14 - Compounds containing amino and esterified hydroxy groups bound to the same carbon skeleton having esterified hydroxy groups and amino groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having at least one of the hydroxy groups esterified by a carboxylic acid having the esterifying carboxyl group bound to a carbon atom of a six-membered aromatic ring
C07C 219/10 - Compounds containing amino and esterified hydroxy groups bound to the same carbon skeleton having esterified hydroxy groups and amino groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having at least one of the hydroxy groups esterified by a carboxylic acid having the esterifying carboxyl group bound to an acyclic carbon atom of a carbon skeleton containing rings
in vitroin vitro transcription (IVT) of messenger RNA (mRNA) using SP6, T7, or KP34 RNA polymerase. In particular, the present disclosure provides in vitro transcription templates with optimized nucleic acid sequences specific for use with SP6, T7, or KP34 RNA polymerase that improve mRNA transcript yield and/or reduce amounts of dsRNA.
C12N 15/63 - Introduction of foreign genetic material using vectorsVectorsUse of hosts thereforRegulation of expression
C07H 21/00 - Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids
The present invention provides a method for monitoring an in vitro transcription (IVT) reaction for the production of RNA within a reaction vessel. The method comprises obtaining a spectrum of a reactant or product during the IVT reaction and comparing the obtained spectrum to a pre-determined reference spectrum of the reactant or product of the IVT reaction. The method can be used to determine changes in the amount of the reactant or product during the IVT reaction.
C12P 19/34 - Polynucleotides, e.g. nucleic acids, oligoribonucleotides
G01N 21/35 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light
Provided are novel lipid nanoparticles for delivering nucleic acids such as mRNA. Also provided are methods of making and using lipid nanoparticles for delivering nucleic acids such as mRNA.
A61K 9/1272 - Non-conventional liposomes, e.g. PEGylated liposomes or liposomes coated or grafted with polymers comprising non-phosphatidyl surfactants as bilayer-forming substances, e.g. cationic lipids or non-phosphatidyl liposomes coated or grafted with polymers
A61K 39/00 - Medicinal preparations containing antigens or antibodies
A61K 39/145 - Orthomyxoviridae, e.g. influenza virus
A61K 39/39 - Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
A61P 31/16 - Antivirals for RNA viruses for influenza or rhinoviruses
38.
ANTI-MENINGOCOCCAL ANTIBODIES FOR IN VITRO IMMUNOASSAY
C07K 14/22 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from bacteria from Neisseriaceae (F), e.g. Acinetobacter
C07K 16/12 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from bacteria
A61K 39/00 - Medicinal preparations containing antigens or antibodies
Provided herein are a class of helper lipids or pharmaceutically acceptable salts thereof. The helper lipids provided herein can be useful for delivery and expression of mRNA and encoded protein, e.g., as a component of a liposomal delivery vehicle, and accordingly can be useful for treating various diseases, disorders and conditions, such as those associated with deficiency of one or more proteins.
A61K 47/54 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
A61K 48/00 - Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseasesGene therapy
C12N 15/88 - Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation using microencapsulation, e.g. using liposome vesicle
A61K 9/1272 - Non-conventional liposomes, e.g. PEGylated liposomes or liposomes coated or grafted with polymers comprising non-phosphatidyl surfactants as bilayer-forming substances, e.g. cationic lipids or non-phosphatidyl liposomes coated or grafted with polymers
40.
ADJUVANTED IMMUNOGENIC COMPOSITION AGAINST NEISSERIA MENINGITIDIS B
The disclosure relates to an immunogenic composition comprising a combination of Neisseria meningitidis serogroup B antigens, said combination comprising at least one factor H binding protein (fHBP) A and at least one factor H binding protein (fHBP) B, and an aluminum hydroxyphosphate (AlPO4) adjuvant, the AlPO4 adjuvant being selected as having a point of zero charge (PZC) below 5.
C07K 14/22 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from bacteria from Neisseriaceae (F), e.g. Acinetobacter
The present invention provides methods of encapsulating messenger RNA in lipid nanoparticles without the use of flammable solvents, and compositions produced by these methods, for mRNA delivery in therapeutic use. In particular, the present invention provides a process of encapsulating messenger RNA in lipid nanoparticles comprising a step of mixing (a) an mRNA solution comprising one or more mRNAs with (b) a lipid solution comprising one or more cationic lipids, one or more non-cationic lipids, one or more PEG-modified lipids, and a solvent, wherein the solvent comprises diethylene glycol monoethyl ether or tert-amyl alcohol, thereby forming mRNA encapsulated within the LNPs.
A61K 31/7105 - Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
Provided herein is a messenger RNA (mRNA) comprising, from 5′ to 3′, a 5′ untranslated region (5′ UTR), at least one open reading frame (ORF), a 3′ untranslated region (3′ UTR), and a GC-rich sequence, wherein the mRNA comprises at least one chemical modification. Also provided are methods of producing a plurality of chemically modified mRNA molecules with polyA sequence lengths of at least about 200 consecutive adenosine nucleotides.
C12N 15/11 - DNA or RNA fragmentsModified forms thereof
A61K 31/7105 - Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
The present disclosure relates to liquid and dried compositions comprising a live, attenuated or genetically modified herpesvirus and methods of preparing such compositions, in one aspect, the composition comprises at least two or more pharmaceutically acceptable exetpients, at least one of which is histidine and at least one of which is a sugar or sugar alcohol. The compostions retain a sufficiently high infectious titre following storage or large-scale manufacturing steps, such as lyophilization.
The present invention relates to a messenger RNA (mRNA)-based immunogenic composition that is capable of inducing a mammalian cell to produce an influenza virus-like particle (VLP). The immunogenic composition comprises one or more mRNAs encoding an influenza virus matrix 1 (M1) protein and one or more influenza virus hemagglutinin (HA) proteins and/or one or more influenza virus neuraminidase (NA) proteins.
The disclosure relates to an immunogenic composition comprising at least one water- soluble polyanionic polymer, at least one nucleic acid carrier comprising at least one cationic, or ionizable cationic, lipid, and at least one nucleic acid encoding at least one antigen.
e.g.e.g., as a component of liposomal delivery vehicle, and accordingly can be useful for treating various diseases, disorders and conditions, such as those associated with deficiency of one or more proteins.
The present disclosure provides methods for eliciting an immune response against respiratory syncytial virus (RSV) in a subject. The present disclosure also provides methods for preventing an RSV infection or reducing one or more symptoms of an RSV infection in a subject.
The present disclosure provides methods of preventing, reducing the risk, or mitigating RSV lower respiratory tract infection by administering nirsevimab.
Methods, systems, and apparatus, including computer programs encoded on a computer storage medium, for selecting a candidate antigen for inclusion in a vaccine using a biological response machine learning model. In one aspect, a method comprises receiving immunization history data for a subject, receiving viral strain data, using a biological response machine learning model to generate a predicted biological response score characterizing a predicted biological response of the subject having the immunization history to being exposed to the viral strain, and outputting the predicted biological response score.
Methods, systems, and apparatus, including computer programs encoded on a computer storage medium, for selecting a candidate antigen for inclusion in a vaccine using a biological response machine learning model. In one aspect, a method comprises obtaining data comprising a set of immunization histories and a set of viral strains, generating a plurality of predicted biological response scores using a biological response machine learning model, and selecting a candidate antigen for inclusion in a vaccine based at least in part on the plurality of predicted biological response scores.
G16B 15/30 - Drug targeting using structural dataDocking or binding prediction
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
G16B 20/00 - ICT specially adapted for functional genomics or proteomics, e.g. genotype-phenotype associations
The present disclosure provides an in vitro system comprising a plurality of isolated human muscle cells and a plurality of lipid-nanoparticle (LNP)-encapsulated messenger RNA (mRNA), and methods of screening LNP-encapsulated mRNA for polypeptide expression with said system.
C12N 5/077 - Mesenchymal cells, e.g. bone cells, cartilage cells, marrow stromal cells, fat cells or muscle cells
A61K 9/127 - Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
A61K 31/7105 - Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
A61K 31/7088 - Compounds having three or more nucleosides or nucleotides
C12N 15/00 - Mutation or genetic engineeringDNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purificationUse of hosts therefor
C12N 15/88 - Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation using microencapsulation, e.g. using liposome vesicle
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing
A system for designing vaccines includes one or more processors, and computer storage storing executable computer instructions in which, when executed by the one or more processers, cause the one or more processors to perform one or more operations. The one or more operations include applying, to a first temporal sequence data set, a plurality of driver models configured to generate output data representing one or more molecular sequences. The one or more operations include, for each of the plurality of driver models, training the driver model. The one or more operations include selecting, based on one or more trained translational responses, a set of trained driver models of the plurality of driver models. The one or more operations include selecting, based on second translational response data, a subset of trained driver models of the set of trained driver models.
G16H 50/70 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients
A61K 39/00 - Medicinal preparations containing antigens or antibodies
G16B 30/00 - ICT specially adapted for sequence analysis involving nucleotides or amino acids
G16B 40/00 - ICT specially adapted for biostatisticsICT specially adapted for bioinformatics-related machine learning or data mining, e.g. knowledge discovery or pattern finding
G16H 10/20 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
G16H 50/80 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for detecting, monitoring or modelling epidemics or pandemics, e.g. flu
G16H 70/40 - ICT specially adapted for the handling or processing of medical references relating to drugs, e.g. their side effects or intended usage
G16H 70/60 - ICT specially adapted for the handling or processing of medical references relating to pathologies
The present disclosure relates to a process for preparing a compound of formula (7), comprising the step of reacting a compound of formula (6) with a reducing agent, and to process for preparing deoxycholic acid or a pharmaceutically acceptable salt thereof comprising said step, and to uses of the deoxycholic acid or a pharmaceutically acceptable salt thereof prepared by the process to extract outer membrane vesicles from Gram-negative bacteria.
C07J 1/00 - Normal steroids containing carbon, hydrogen, halogen, or oxygen, not substituted in position 17 beta by a carbon atom, e.g. oestrane, androstane
C07J 9/00 - Normal steroids containing carbon, hydrogen, halogen, or oxygen, substituted in position 17 beta by a chain of more than two carbon atoms, e.g. cholane, cholestane, coprostane
C07J 13/00 - Normal steroids containing carbon, hydrogen, halogen, or oxygen, having a carbon-to-carbon double bond from or to position 17
C07J 43/00 - Normal steroids having a nitrogen-containing hetero ring spiro-condensed or not condensed with the cyclopenta[a]hydrophenanthrene skeleton
C07J 51/00 - Normal steroids with unmodified cyclopenta[a]hydrophenanthrene skeleton not provided for in groups
A61K 8/00 - Cosmetics or similar toiletry preparations
A61P 37/00 - Drugs for immunological or allergic disorders
55.
Protein-Saccharide Conjugation with Sodium Cyanoborohydride
Methods and uses of conjugating saccharides to protein carriers are disclosed herein. Exemplary conjugates prepared according to those methods and uses are also disclosed. Additionally, methods for quantifying the amount of sodium borohydride in a sodium cyanoborohydride reagent are disclosed herein. Vaccine compositions as well as related methods and uses are also disclosed herein.
A61K 39/385 - Haptens or antigens, bound to carriers
A61K 47/64 - Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
G01N 24/08 - Investigating or analysing materials by the use of nuclear magnetic resonance, electron paramagnetic resonance or other spin effects by using nuclear magnetic resonance
56.
COMPOSITIONS AND METHODS FOR CIRCULAR RNA AFFINITY PURIFICATION
The present disclosure provides for circular RNA (circRNA) compositions and methods purification and use of the same. In particular, the disclosure relates to compositions and methods of making and using circRNA comprising one or more aptamers which specifically bind an affinity ligand.
This application relates to modified RNA polymerases, compositions or kits comprising the same, and methods of using the same, in particular, in the preparation of ribonucleic acids (RNAs), such as messenger RNAs (mRNAs), in in vitro transcription reactions.
A discrete-data object is received and may include a plurality of first discrete values, the discrete-data object may include one or more amino acid sequences. The discrete-data object is converted into a continuous-data object that may include a plurality of first continuous values. To the continuous-data object, a continuous-data algorithm is applied to generate a continuous-result object that may include a plurality of second continuous values. The continuous-result object is converted into a discrete-result object which may include a plurality of second discrete values. A vaccine is manufactured which may include at least one of the group that may include i) a protein defined by the discrete-result object, ii) a nucleic acid capable of producing the protein defined by the discrete-result object, and iii) a delivery vehicle capable of producing the protein defined by the discrete-result object.
One or more data objects are received defining a plurality of wild-type amino acid sequences. From the one or more data objects, a plurality of reduced-dimension sequences are generated in a reduced-dimension space. A plurality of candidate sequences are generated in the reduced-dimension space using the plurality of reduced-dimension sequences. One or more data objects defining a viral amino acid sequence are received. Viral sequences in the reduced-dimension space are received. As input to a titer-predictor, each of the candidate sequences and at least one of the reduced-dimension viral sequences are provided. As output from the titer-predictor, a candidate-score for each of the candidate sequences is received. At least one candidate sequence from among the candidate sequences are selected. At least one new amino acid sequence is generated. Each of the generated amino acid sequences is suitable for manufacturing a respective vaccine.
G16B 40/00 - ICT specially adapted for biostatisticsICT specially adapted for bioinformatics-related machine learning or data mining, e.g. knowledge discovery or pattern finding
Provided herein is a nucleic acid (e.g., messenger RNA) vaccine encoding at least one antigenic prokaryotic polypeptide linked to one or both of a viral secretion signal peptide and a transmembrane domain. Also provided are methods of vaccination against a prokaryotic infection with the nucleic acid described herein.
A61K 9/1272 - Non-conventional liposomes, e.g. PEGylated liposomes or liposomes coated or grafted with polymers comprising non-phosphatidyl surfactants as bilayer-forming substances, e.g. cationic lipids or non-phosphatidyl liposomes coated or grafted with polymers
C12N 7/00 - Viruses, e.g. bacteriophagesCompositions thereofPreparation or purification thereof
C12N 15/88 - Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation using microencapsulation, e.g. using liposome vesicle
63.
HPLC-BASED ASSAYS FOR DETECTING MULTIPLE MRNA CONSTRUCTS
The disclosure relates to methods for detecting at least a first mRNA and a second mRNA or two or more mRNAs in a multi-mRNA composition using reverse-phase high pressure liquid chromatography (RP-HPLC). The methods are particularly suitable for analyzing multi- mRNA compositions comprising first and second mRNAs or two or more mRNAs of similar lengths. The disclosed methods also find utility in assessing the quality and/or integrity of each of the at least first and second mRNAs or two or more mRNAs in a multi-mRNA composition. In addition, the disclosed methods can be used to calculate the proportion of each mRNA in a multi-mRNA composition.
The disclosure relates to lipidic compounds of formula (I): A—(CH2)n—CX—B—Z—R1 (I) wherein R1 represents a lipophilic or hydrophobic tail-group, wherein RI is an optionally substituted, branched, saturated or unsaturated, C10 to C55 hydrocarbon radical, and which hydrocarbon skeleton that is optionally interrupted by one or several atoms of oxygen or nitrogen and/or one or several moiety —(C═O)—, —O—(C═O)— or —(C═O)—O— and which one nitrogen atom, if present in the skeleton, can be linked, directly or not, to said Z radical; Z is a spacer arm; B represents O or NH; X is O or S; n is 0, 1, 2, 3, 4, 5 or 6; and A represents (i) R2R3N-, (ii) NR2R3-Alk-Y-in which Y is O or N, Alk is an alkylene moiety in C2 to C6 and R2 and R3 represent independently of each other a linear or branched (C1-C6) alkyl group, or (iii) a 4- to 8-membered saturated heterocyclic radical comprising 3 to 7 carbon atoms and 1 or 2 nitrogen atoms, said 4- to 8-membered saturated heterocyclic radical being linked to the rest of the molecule by a carbon atom or a nitrogen atom and being optionally substituted by 1 to 4 substituents, independently of each other, selected from a linear or branched (C1-C6) alkyl group; or one of its pharmaceutically acceptable salts thereof; and with said compound that is in all the possible racemic, enantiomeric and diastereoisomeric isomer forms.
A61K 9/1272 - Non-conventional liposomes, e.g. PEGylated liposomes or liposomes coated or grafted with polymers comprising non-phosphatidyl surfactants as bilayer-forming substances, e.g. cationic lipids or non-phosphatidyl liposomes coated or grafted with polymers
A61K 39/00 - Medicinal preparations containing antigens or antibodies
A61K 39/145 - Orthomyxoviridae, e.g. influenza virus
A61P 31/16 - Antivirals for RNA viruses for influenza or rhinoviruses
C07C 229/12 - Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having only one amino and one carboxyl group bound to the carbon skeleton the nitrogen atom of the amino group being further bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings to carbon atoms of acyclic carbon skeletons
C07C 237/08 - Carboxylic acid amides, the carbon skeleton of the acid part being further substituted by amino groups having the carbon atoms of the carboxamide groups bound to acyclic carbon atoms of the carbon skeleton the carbon skeleton being acyclic and saturated having the nitrogen atom of at least one of the carboxamide groups bound to an acyclic carbon atom of a hydrocarbon radical substituted by singly-bound oxygen atoms
C07D 207/16 - Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals
C07D 211/34 - Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having no double bonds between ring members or between ring members and non-ring members with hydrocarbon or substituted hydrocarbon radicals directly attached to ring carbon atoms with substituted hydrocarbon radicals attached to ring carbon atoms with hydrocarbon radicals, substituted by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals
C07D 211/62 - Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals attached in position 4
C07D 295/15 - Heterocyclic compounds containing polymethylene-imine rings with at least five ring members, 3-azabicyclo [3.2.2] nonane, piperazine, morpholine or thiomorpholine rings, having only hydrogen atoms directly attached to the ring carbon atoms with substituted hydrocarbon radicals attached to ring nitrogen atoms substituted by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals with the ring nitrogen atoms and the carbon atoms with three bonds to hetero atoms attached to the same carbon chain, which is not interrupted by carbocyclic rings to an acyclic saturated chain
Provided herein are methods of purifying messenger RNA (mRNA) by subjecting a preparation comprising in vitro synthesized mRNA to one or more steps of enzymatic digestion with a proteinase, optionally with a further oligo dT affinity chromatography step. Also provided are mRNA purified by the methods described herein.
Provided herein are methods of purifying messenger RNA (mRNA) by subjecting a preparation comprising in vitro synthesized mRNA to one or more steps of enzymatic digestion with a proteinase, optionally with a further oligo dT affinity chromatography step. Also provided are mRNA purified by the methods described herein.
This application relates to modified influenza B hemagglutinin polypeptides and nucleic acids, such as messenger ribonucleic acids (mRNAs), encoding the same, as well as compositions comprising the same, vaccines comprising the same, and methods of using the same, such as in the prevention and/or treatment of diseases or conditions caused by influenza B viruses.
The present disclosure provides a Lyme disease vaccine, comprising a messenger RNA (mRNA) comprising an open reading frame (ORF) encoding at least one antigenic polypeptide derived from at least one bacteria of the genus Borrelia, and methods of eliciting an immune response by administering said vaccine.
The present disclosure provides compositions comprising at least two messenger RNAs (mRNAs) consisting of a human respiratory syncytial virus (hRSV or RSV) F protein antigen, a human metapneumovirus (hMPV) F protein antigen, and/or a human parainfluenza virus 3 (hPIV3 or PIV3) F protein antigen, and methods of eliciting an immune response by administering said compositions.
A61K 31/34 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
C12N 15/10 - Processes for the isolation, preparation or purification of DNA or RNA
C12N 15/67 - General methods for enhancing the expression
C12P 19/34 - Polynucleotides, e.g. nucleic acids, oligoribonucleotides
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
THE UNITED STATES OF AMERICA, AS REPRESENTED BY THE SECRETARY, DEPARTMENT OF HE (USA)
Inventor
Chan, Yvonne
Sasmal, Sukanya
Stuebler, Antonia
Kishko, Michael
Mundle, Sophia
Zhang, Linong
Dinapoli, Josh
Alamares-Sapuay, Judith
Anosova, Natalie
Chivukula, Sudha
Danz, Hillary
Strugnell, Tod
Groppo, Rachel
Collins, Peter
Buchholz, Ursula
Munir, Shirin
Dahal, Bibha
Abstract
The present disclosure provides a human metapneumovirus (hMPV) vaccine comprising an hMPV F protein antigen, and methods of eliciting an immune response by administering said vaccine.
The present disclosure relates to an immunogenic composition comprising a combination of meningococcal antigens which comprises at least one factor H binding protein (fHBP) A protein, at least one fHBP B protein, at least one Neisseria adhesin A (NadA) protein, and at least one detergent-extracted Outer Membrane Vesicle (dOMV). The meningococcal antigens may be from a Neisseria meningitidis serogroup B. The combination of antigens provided a broad coverage of bacteria strains. Further, the present disclosure relates to the use of the immunogenic composition in methods for eliciting an immune response.
The present invention relates to a method for freezing or freeze-drying lipid nanoparticles (LNPs) comprising at least a nucleic acid and, at least, as lipid components, a cationic ionizable lipid, a neutral lipid, and a steroid alcohol, or an ester thereof. The method comprises the steps of providing a liquid composition comprising said LNPs, spraying the composition of step a) in conditions suitable for obtaining liquid droplets, and freezing the liquid droplets obtained at step b) to obtain frozen LNPs. The method may also comprise a step of drying the frozen LNPs obtained to obtain freeze-dried LNPs. The invention also relates to frozen and freeze-dried LNPs.
A61K 31/7105 - Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
78.
SYSTEMS AND DEVICES FOR FILTERING BIOLOGICAL PRODUCTS AND METHODS OF USING THE SAME
Systems and devices for filtering biological products and methods of using the same are provided. A filtration system can include a filtration skid configured to be adapted for engagement with components of a single-use assembly for facilitating one or more unit operations of a continuous filtering process for the one or more biological products. The filtration skid can include a pump cart and a filtration cart. The filtration cart can include a first filter support assembly configured to support a first filtering flow channel and a second filter support assembly configured to support a second filtering flow channel.
A dose divider for releasable attachment to a plunger rod of a syringe comprises first and second arms. A front portion of the first arm and the front portion of the second arm form a channel therebetween for receiving the plunger rod. A resilient hinge pivotably couples the first arm and the second arm such that the dose divider is reversibly movable between first and second configurations. When the dose divider is in the second configuration, the dose divider is configured to receive the plunger rod in the channel through an opening formed between the front portions of the first and second arms. The channel has a shape configured to receive a specific outer shape of the plunger rod. The front portions of the first and second arms are closer when the dose divider is in the first configuration than when the dose divider is in the second configuration.
A61M 15/08 - Inhaling devices inserted into the nose
B05B 11/02 - Membranes or pistons acting on the contents inside the container, e.g. follower pistons
F16B 2/22 - Clips, i.e. with gripping action effected solely by the inherent resistance to deformation of the material of the fastening of resilient material, e.g. rubbery material
C. acnes antigens and antigen combinations, used in the form of nucleic acids (e.g. mRNAs) encoding antigenic proteins or in the form of recombinant protein antigens.
A medicament delivery system comprises a syringe and a plunger rod. The plunger rod comprises a first region of a first outer configuration and a second region of a second outer configuration that is different to the first outer configuration. A blocking element is configured to be provided at a proximal end of the syringe and disposed around the plunger rod, and which permits the plunger rod to move over a first range of motion relative to the syringe to expel a first dose of medicament, and blocks the plunger rod from moving over a subsequent range of motion relative to the syringe to expel further medicament. The blocking element is configured to be removable from the plunger rod. The plunger rod is free to move over the subsequent range of motion relative to the syringe to expel further medicament once the blocking element is removed from the plunger rod.
A delivery system comprises a syringe having a chamber for containing medicament and an outlet through which medicament can be expelled. A plunger rod is moveable relative to the syringe and configured to cause medicament to be expelled from the syringe when medicament is within the syringe and the plunger rod is moved. A disc, when the delivery system is in a first configuration, permits the plunger rod to move over a first range of motion relative to the syringe to expel a first dose of medicament, and blocks the plunger rod from moving over a subsequent range of motion relative to the syringe to expel further medicament. The disc or the plunger rod is rotatable to put the delivery system into a second configuration, in which the plunger rod is free to move over the subsequent range of motion relative to the syringe to expel further medicament
A method of using a dose divider comprising first and second arms, each having a front portion that together form a channel for receiving a syringe plunger rod. A resilient hinge pivotably couples the first and second arms such that the dose divider is reversibly movable between first and second configurations. In the second configuration, the dose divider is configured to receive the plunger rod in the channel formed between the front portions of the first and second arms. The channel is configured to receive a specific outer shape of the plunger rod. The front portions of the first and second arms are closer when the dose divider is in the first configuration than when in the second configuration. The method comprises moving the dose divider from the first configuration to the second configuration by applying a force to the first and second arms such that the first arm pivots in a first direction with respect to the second arm using the resilient hinge.
A medicament delivery system comprises a syringe, a plunger rod is, and a guide element at a proximal end of the syringe and comprising an aperture through which the plunger rod extends. The guide element and the plunger rod are relatively rotatable between blocking and release positions. A guide mechanism provided on the plunger rod and the guide element permits the plunger rod to move axially over a first range of motion relative to the syringe from an initial position to an intermediate position to expel a first dose of medicament, and blocks the plunger rod from moving over a subsequent range of motion relative to the syringe. The plunger rod is free to move in an axial direction over the subsequent range of motion to expel further medicament upon relative rotation of the guide element and the plunger rod from the blocking position to the release position.
Provided are modified influenza virus subtype 2 neuraminidase molecules lacking all or substantially all of the stalk region that form active, soluble tetrameric neuraminidase when expressed in host cells and vaccine compositions comprising the tetrameric neuraminidase or a nucleic acid encoding the modified monomeric influenza virus subtype 2 neuraminidase molecules that forms tetrameric NA when expressed in a cell. Also provided are methods of using the vaccine compositions to vaccinate or immunize a subject against influenza virus.
The present disclosure provides methods and compositions for RNA affinity purification. In particular, the disclosure relates to compositions and methods of making and using mRNA comprising one or more aptamers which specifically bind an affinity ligand.
Disclosed herein are hybrid multivalent vaccine or immunogenic compositions comprising (i) one or more influenza virus proteins selected from one or more influenza virus hemagglutinin (HA) proteins, one or more influenza virus neuraminidase (NA) proteins, or a combination thereof; and (ii) one or more ribonucleic acid molecules encoding one or more influenza virus proteins selected from one or more influenza virus HA proteins, one or more influenza virus NA proteins, or a combination thereof. Also disclosed are methods of using the vaccine or immunogenic compositions.
Disclosed herein are multivalent vaccine or immunogenic compositions comprising one or more recombinant influenza virus hemagglutinin (HA), one or more recombinant influenza virus neuraminidase (NA), and an optional adjuvant. Also disclosed are methods of using the vaccine or immunogenic composition.
Disclosed are multivalent vaccine or immunogenic compositions comprising influenza virus hemagglutinin (HA) from standard of care influenza virus strains, or ribonucleic acid molecules encoding the same; and one or more influenza virus HA identified or designed by machine learning, or one or more ribonucleic acid molecules that encode the influenza virus HA identified or designed by machine learning. Also disclosed are methods of using the vaccine or immunogenic compositions.
Provided are novel vaccines for prophylactic treatment of SARS-COV-2 infections and COVID-19 and methods of making the vaccines, wherein the vaccines contain an oil-in-water emulsion comprising tocopherol and squalene.
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
C07C 219/06 - Compounds containing amino and esterified hydroxy groups bound to the same carbon skeleton having esterified hydroxy groups and amino groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having the hydroxy groups esterified by carboxylic acids having the esterifying carboxyl groups bound to hydrogen atoms or to acyclic carbon atoms of an acyclic saturated carbon skeleton
C07C 229/16 - Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having only one amino and one carboxyl group bound to the carbon skeleton the nitrogen atom of the amino group being further bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings to carbon atoms of hydrocarbon radicals substituted by amino or carboxyl groups, e.g. ethylenediamine-tetra-acetic acid, iminodiacetic acids
C07C 235/06 - Carboxylic acid amides, the carbon skeleton of the acid part being further substituted by oxygen atoms having carbon atoms of carboxamide groups bound to acyclic carbon atoms and singly-bound oxygen atoms bound to the same carbon skeleton the carbon skeleton being acyclic and saturated having the nitrogen atoms of the carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms
Provided are novel lipid nanoparticles for delivering nucleic acids such as mRNA. Also provided are methods of making and using lipid nanoparticles for delivering nucleic acids such as mRNA.
