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1.发明申请METHOD OF MICROWAVE VACUUM DRYING SPHERICAL-SHAPED PELLETS OF BIOLOGICAL MATERIALS 审中-公开微波真空干燥方法生物材料的球形颗粒公开(公告)号：US20160252300A1
公开(公告)日：2016-09-01
申请号：US15029062
申请日：2014-10-13
申请人： Akhilesh BHAMBHANI , Robert K. EVANS , Rebecca LIZZANO , Jessica Sinacola , MERCK SHARP & DOHME CORP.
CPC分类号： F26B5/048 , A61K9/0014 , A61K39/15 , A61K2039/525 , C07K1/00 , C12N7/00 , C12N2720/12334 , F26B2200/08
摘要： Methods for preparing dried pellets of biological materials are described. The pellets can have a substantially spherical shape and are prepared by freezing droplets of a liquid composition of a desired biological material on a solid surface followed by microwave vacuum drying the frozen droplets. These methods are useful for preparing dried pellets having a high concentration of a desired biological material, in particular a therapeutic protein or vaccine, and which have a faster reconstitution time than lyophilized powder cakes prepared in vials.
摘要翻译： 描述了制备生物材料干颗粒的方法。 颗粒可以具有基本上球形的形状，并且通过将所需生物材料的液体组合物的液滴冷冻在固体表面上，然后微波真空干燥冷冻液滴来制备。 这些方法可用于制备具有高浓度所需生物材料，特别是治疗性蛋白质或疫苗的干燥颗粒，并且其比在小瓶中制备的冻干粉饼具有更快的重构时间。
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2.发明申请公开(公告)号：US20210252125A1
公开(公告)日：2021-08-19
申请号：US17049245
申请日：2019-04-25
申请人： Patrick Leonard AHL , Akhilesh BHAMBHANI , Christopher Jon FARRELL , Patrick MCHUGH , Morrisa C. JONES , Daniel D. ROTH , Jessica R. SINACOLA , Justin STANBRO , Matthew P. WATSON , Emily WEN , Michael A. WINTERS , Merck Sharp & Dohme Corp.
发明人： Patrick Leonard Ahl , Akhilesh Bhambhani , Christopher Jon Farrell , Patrick McHugh , Morrisa C. Jones , Daniel D. Roth , Jessica R. Sinacola , Justin Stanbro , Matthew P. Watson , Emily Wen , Michael A. Winters
摘要： A method is described for producing a pneumococcal capsular polysaccharide protein conjugate in which one or more activated pneumococcal polysaccharides of particular pneumococcal serotypes and carrier protein are separately lyophilized, the separately lyophilized polysaccharides and carrier protein are separately reconstituted in an organic solvent, and the reconstituted polysaccharide and carrier protein are then combined together by Tee-mixing and conjugated together to produce polysaccharide carrier protein conjugates. A plurality of conjugates, each comprising polysaccharides of a particular serotype, may be used to produce multivalent pneumococcal immunogenic compositions having a combination of conjugates for use in vaccines.
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3.发明申请公开(公告)号：US20160250319A1
公开(公告)日：2016-09-01
申请号：US15029064
申请日：2014-10-13
IPC分类号： A61K39/155 , A61K47/26 , C12N7/00
CPC分类号： A61K39/155 , A61K9/19 , A61K39/12 , A61K47/26 , A61K2039/5254 , C12N7/00 , C12N2760/18521 , C12N2760/18534 , C12N2760/18551
摘要： Methods for improving the drying yield and stability of RSV vaccines comprising a highly thermolabile enveloped live virus and/or one or more RSV protein subunits, are described. Methods for rapid drying of RSV formulations containing between 17.5% and 60% w/w of a non-polymeric sugar and using either conduction or radiation dominant drying mechanisms, are disclosed. The disclosed methods provide for; 1) a dried RSV formulation with improved stability profile; 2) faster drying; and 3) integration of dried RSV into a primary device (such as dual chamber cartridges, foil-pouch devices etc.), pre- as well as post-drying.
摘要翻译： 描述了改善包含高度不耐热的包膜活病毒和/或一个或多个RSV蛋白亚基的RSV疫苗的干燥产率和稳定性的方法。 公开了用于快速干燥含有17.5％至60％w / w的非聚糖的RSV制剂的方法，并且使用传导或辐射优势的干燥机理。 所公开的方法规定; 1）具有改善的稳定性特征的干燥的RSV制剂; 2）干燥速度更快; 以及3）将干燥的RSV整合到主要装置（例如双室筒，箔袋装置等）中，以及干燥后。
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4.发明申请公开(公告)号：US20220265558A1
公开(公告)日：2022-08-25
申请号：US17628711
申请日：2020-07-23
申请人： Akhilesh | Bhambhani , Morrisa Jones , Derrick M. Smith , David S. Thiriot , Joseph M. Rock , Merck Sharp & Dohme Corp.
摘要： Disclosed herein are methods for preparing and/or dispensing lyospheres of pharmaceutical compositions of biologics (e.g., vaccines, therapeutic proteins such as monoclonal antibodies) or small molecules (e.g., chemical compounds). Also described are assemblies and systems for preparing and/or dispensing the lyospheres.
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公开(公告)号：US20150307606A1
公开(公告)日：2015-10-29
申请号：US14650605
申请日：2013-12-09
申请人： Ashwin BASARKAR , Akhilesh BHAMBHANI , Ramesh KASHI , Shona P. MEHTA , MERCK SHARP & DOHME CORP.
CPC分类号： C07K16/244 , A61K9/0019 , A61K9/1688 , A61K9/19 , A61K39/39591 , C07K2317/565 , C07K2317/94 , F26B5/06
摘要： Methods for preparing lyophilized pellets of antibodies that specifically bind to human IL-23 are described. The pellets have a substantially spherical shape and are prepared by freezing droplets of a liquid composition of a desired biological material on a flat, solid surface, in particular, a surface that does not have any cavities, followed by lyophilizing the frozen droplets. These methods are useful for preparing lyophilized pellets having a high concentration of anti-IL-23 antibody, and which have a faster reconstitution time than lyophilized powder cakes prepared in vials. Also provided are improved formulations for use in preparing lyophilized forms of antibodies that specifically bind to human IL-23.
摘要翻译： 描述了制备特异性结合人IL-23的抗体冻干颗粒的方法。 颗粒具有基本上球形的形状，并且通过在平坦的固体表面，特别是没有任何空腔的表面上冷冻所需生物材料的液体组合物的液滴，然后冻结冷冻液滴来制备。 这些方法可用于制备具有高浓度抗IL-23抗体的冻干颗粒，并且比在小瓶中制备的冻干粉饼具有更快的重构时间。 还提供了用于制备特异性结合人IL-23的抗体的冻干形式的改进制剂。
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公开(公告)号：US20210223262A1
公开(公告)日：2021-07-22
申请号：US15734346
申请日：2019-06-03
申请人： Akhilesh BHAMBHANI , Thorsten VERCH , Morrisa C. JONES , Mary RETZLAFF , Jessica R. SINACOLA , Silikhone L. BOUARAPHAN , Merck Sharp & Dohme Corp.
发明人： Akhilesh Bhambhani , Thorsten Verch , Morrisa C. Jones , Mary Retzlaff , Jessica R. Sinacola , Silikhone L. Bouaraphan
摘要： The present invention provides lyophilized pellets of low concentrations of antibodies in the form of lyospheres. These lyospheres provide pre-measured antibody concentrations suitable for diagnostic and quality control assays.
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公开(公告)号：US20200325020A1
公开(公告)日：2020-10-15
申请号：US16759167
申请日：2018-10-22
申请人： Akhilesh BHAMBHANI , Muneeswara Babu MEDI , Maya SALNIKOVA , James William SMITH , David S. THIRIOT , Merck Sharp & Dohme Corp.
发明人： Akhilesh Bhambhani , Muneeswara Babu Medi , Maya Salnikova , William James Smith , David S. Thiriot
摘要： Vaccine formulations are described comprising physically separated, lyophilized antigens and adjuvant components, which may be in lyoparticle form, as well as methods of using and making such formulations. Reconstituted formulations are also described.
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公开(公告)号：US20220105169A1
公开(公告)日：2022-04-07
申请号：US17554354
申请日：2021-12-17
发明人： Ramesh V. Chintala , Akhilesh Bhambhani , Christopher David Mensch , Denise K. Nawrocki , Jeffrey Thomas Blue
摘要： The present invention provides polysaccharide-protein conjugate vaccine formulations comprising a buffer, surfactant, sugar, alkali or alkaline salt, aluminum adjuvant, optionally a bulking agent, and optionally a polymer.
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公开(公告)号：US20210048247A1
公开(公告)日：2021-02-18
申请号：US17081484
申请日：2020-10-27
摘要： Methods for preparing dried pellets of biological materials are described. The pellets can have a substantially spherical shape and are prepared by freezing droplets of a liquid composition of a desired biological material on a solid surface followed by microwave vacuum drying the frozen droplets. These methods are useful for preparing dried pellets having a high concentration of a desired biological material, in particular a therapeutic protein or vaccine, and which have a faster reconstitution time than lyophilized powder cakes prepared in vials.
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公开(公告)号：US20180311172A1
公开(公告)日：2018-11-01
申请号：US15768044
申请日：2016-10-11
CPC分类号： A61K9/5042 , A61K9/1623 , A61K9/1652 , A61K9/5026
摘要： The present invention provides a process for preparing enterically-coated lyospheres comprising a therapeutic agent comprising: a.) providing lyospheres comprising the therapeutic agent; b.) coating said lyospheres with an enteric polymer coating composition; and c.) isolating said enterically-coated lyospheres. In other embodiments, the invention provides dosage forms comprising a lyosphere comprising an effective amount of a therapeutic agent and an enteric polymer coating. In some embodiments, the therapeutic agent in the process or dosage form is a polypeptide, a protein, a peptide, a lipopeptide, a glycoprotein, a fusion protein, a protein conjugate, a cytokine, an enzyme, an antibody, an oligonucleotide, a vaccine vector, small molecule, a live virus, an inactivated virus, a virus-like particle, a viral protein subunit, an adjuvant, microbiome, a prebiotic, a probiotic, or an ectobiotic. In some embodiments of the present invention, after oral administration the dosage forms containing the enterically-coated lyospheres provide a method of delivering a therapeutic agent to the ileum, ileo-caecal junction, colon or a combination thereof in a subject.
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