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公开(公告)号：US09827303B2
公开(公告)日：2017-11-28
申请号：US14382258
申请日：2013-03-05
发明人： Heleen Kraan , Jean-Pierre Amorij
CPC分类号： A61K39/13 , A61K9/19 , A61K39/12 , A61K47/02 , A61K47/183 , A61K47/26 , C12N7/00 , C12N2770/32634 , Y02A50/466
摘要： The present invention relates to methods for producing dried formulations of biopharmaceutical agents that aim to minimize the loss of activity of the agents upon drying and to provide dried formulations with an extended shelf life. The method comprises the step of drying an aqueous solution comprising, in addition to the biopharmaceutical agent, at least an amino acid, a polyol and a metal salt. Preferably the amino acid is glutamate, the polyol is sorbitol and optionally also mannitol and the metal salt is a magnesium salt. The solution is dried by vacuum drying or by lyophilization. The methods are particularly useful for preparing dried formulations of viruses such as poliovirus or respiratory syncytial virus to be used for vaccination. The invention also relates to dried formulations prepared in accordance with the methods of the invention and to their use as medicaments, e.g. as vaccines.
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公开(公告)号：US11292808B2
公开(公告)日：2022-04-05
申请号：US16072895
申请日：2017-01-27
IPC分类号： C07H15/06 , C12N1/20 , A61K39/095 , A61P31/04 , A61K31/7024 , C12R1/36
摘要： The present invention relates to neisserial LPS having a hexa-acylated lipid A moiety, wherein the hexa-acylated lipid A moiety is modified as compared to the lipid A moiety of a wild-type neisserial LPS in that it comprises a palmitoleoyl instead of a lauroyl secondary acyl chain on the glucosamine at the non-reducing end of the lipid A moiety. The invention further relates to mixtures of the hexa-acylated LPS with the corresponding penta-acylated LPS, lacking a secondary acyl chain on the glucosamine at the non-reducing end of the lipid A moiety. The invention also relates to neisserial bacteria that have been genetically modified to reduce expression of the endogenous lpxL1 gene and to introduce expression of a heterologous thermosensitive lpxP gene for producing the hexa- and penta-acylated LPS. By selecting the time and/or temperature at which the bacterium is grown, it is feasible to increase or decrease the amount of hexa-acylated lipid A structure relative to the corresponding penta-acylated structure and thereby modulate the TLR4 agonist activity of the neisserial LPS of the invention, to the exact level of activity required for a particular immunotherapeutic approach.
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公开(公告)号：US11291713B2
公开(公告)日：2022-04-05
申请号：US16493309
申请日：2018-03-13
发明人： Peter André van der Ley , Jesús Andrés Arenas Busto , Elder Pupo Escalona , Johannes Petrus Maria Tommassen
摘要： The current invention lies in the field of medicine and more specifically in the field of vaccinology. The current invention concerns a novel Bordetella LPS and a modified bacterium of the genus Bordetella comprising such modified LPS. The LPS of the invention has a reduced endotoxicity in comparison to an unmodified Bordetella LPS. The modified LPS of the invention is therefore particularly suitable for use in inducing or stimulating an immune response in a subject, wherein the immune response is induced or stimulated against a Bordetella infection. The modified Bordetella LPS of the invention is obtainable by introducing in a Bordetella cell the expression of a heterologous acyl transferase. In particular, the modified Bordetella cell of the invention has an increased expression of an heterologous LpxA, LpxL or LpxD acyl transferase.
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4.发明授权公开(公告)号：US09707286B2
公开(公告)日：2017-07-18
申请号：US15045424
申请日：2016-02-17
IPC分类号： C12N1/00 , A61K39/095 , A61K35/74 , C12N1/20 , A61K39/00
CPC分类号： A61K39/095 , A61K35/74 , A61K2039/522 , A61K2039/523 , A61K2039/55505 , A61K2039/70 , C12N1/20 , C12N2500/10 , C12N2500/60
摘要： The present invention relates to the fields of medical microbiology and vaccines. In particular the invention relates to a process for detergent-free preparation of outer membrane vesicles (OMV) of Gram negative bacteria for use in vaccines, to OMV obtainable by said process, and to a pharmaceutical composition comprising such OMV. The present invention further relates to the use of OMV of the present invention as a medicament in particular for use in a method for eliciting an immune response.
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公开(公告)号：US11542467B2
公开(公告)日：2023-01-03
申请号：US16768919
申请日：2018-12-04
IPC分类号： C12N1/20 , A61K39/02 , A61K39/09 , A61K39/108 , A61K39/00
摘要： The present invention relates to the fields of medical microbiology and vaccines. In particular the invention relates to a process wherein the spontaneous release of bacterial outer membrane vesicles (OMV) of Gram-negative bacteria is stimulated by application of a dissolved oxygen tension (DOT) that is higher than a physiological DOT. The thus produced OMVs are for use in vaccines. The invention further relates to OMV obtainable by said process, and to a pharmaceutical composition comprising such OMV. The present invention further relates to the use of OMV of the present invention as a medicament in particular for use in a method for eliciting an immune response.
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公开(公告)号：US10335479B2
公开(公告)日：2019-07-02
申请号：US15795545
申请日：2017-10-27
发明人： Heleen Kraan , Jean-Pierre Amorij , Rimko Ten Have
摘要： The present invention relates to methods for producing dried formulations of biopharmaceutical agents that aim to minimize the loss of activity of the agents upon drying and to provide dried formulations with an extended shelf life. The method comprises the step of drying an aqueous solution comprising, in addition to the biopharmaceutical agent, at least an amino acid, a polyol and a metal salt. Preferably the amino acid is glutamate, the polyol is sorbitol and optionally also mannitol and the metal salt is a magnesium salt. The solution is dried by vacuum drying or by lyophilization. The methods are particularly useful for preparing dried formulations of viruses such as poliovirus or respiratory syncytial virus to be used for vaccination. The invention also relates to dried formulations prepared in accordance with the methods of the invention and to their use as medicaments, e.g. as vaccines.
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公开(公告)号：US10080793B2
公开(公告)日：2018-09-25
申请号：US14898654
申请日：2014-06-17
IPC分类号： A61K39/13 , C12N7/00 , A61K39/12 , A61K39/145 , A61K39/00
CPC分类号： A61K39/13 , A61K39/12 , A61K39/145 , A61K2039/5252 , A61K2039/545 , C12N7/00 , C12N2760/16051 , C12N2760/16134 , C12N2760/18051 , C12N2770/32051 , C12N2770/32351 , C12N2770/32634 , C12N2770/32651 , C12N2770/32663 , Y02A50/466
摘要： The present invention relates to a method for prevention and/or reduction of aggregation of viral components.
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