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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：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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3.发明申请公开(公告)号：US20160193324A1
公开(公告)日：2016-07-07
申请号：US14916458
申请日：2014-09-02
申请人： Brian K. MEYER , Robert K. EVANS , Channing R. BEALS , David C. KASLOW , Merck Sharp & Dohme Corp.
IPC分类号： A61K39/25 , A61K39/145 , A61K39/165 , A61K39/102 , A61K39/05 , A61K39/08 , A61K39/02 , A61K39/13 , C12N7/00 , A61K39/20
CPC分类号： A61K39/25 , A61K39/05 , A61K39/08 , A61K39/099 , A61K39/102 , A61K39/12 , A61K39/13 , A61K39/145 , A61K39/165 , A61K39/20 , A61K2039/5252 , A61K2039/5254 , A61K2039/54 , A61K2039/55 , C12N7/00 , C12N2710/16734 , C12N2760/16034 , C12N2760/18434 , C12N2770/32634 , C12N2770/36234
摘要： The present invention relates to a method of vaccinating a patient against varicella zoster virus (VZV) by delivery of an effective amount of a live attenuated VZV vaccine to the epidermis or the dermis of a patient's skin at a depth of between about 100 and about 700 microns from the surface of the skin, which is useful for preventing herpes zoster or reducing the severity or duration thereof. In embodiments of the invention, the patient is 50 years of age or older and has been previously exposed to VZV. The invention also relates to a method of preventing VZV infection in an individual who was not previously infected with VZV comprising administering an effective amount of a live attenuated VZV vaccine to the epidermis or the dermis of the individual's skin at a depth of between about 100 and about 700 microns from the surface of the skin.
摘要翻译： 本发明涉及一种通过将有效量的活减毒VZV疫苗递送至患者皮肤的表皮或真皮的约100至约700埃的深度来接种患者抗水痘带状疱疹病毒（VZV）的方法 从皮肤表面微米，其可用于预防带状疱疹或降低其严重性或持续时间。 在本发明的实施方案中，患者为50岁或以上，并且先前已经暴露于VZV。 本发明还涉及一种在先前未感染VZV的个体中预防VZV感染的方法，其包括以约100至约100的浓度施用有效量的活减毒VZV疫苗至个体皮肤的表皮或真皮， 距离皮肤表面约700微米。
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公开(公告)号：US20190383556A1
公开(公告)日：2019-12-19
申请号：US16556662
申请日：2019-08-30
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：US20160228532A1
公开(公告)日：2016-08-11
申请号：US15029060
申请日：2014-10-13
CPC分类号： A61K39/12 , A61K9/0019 , A61K9/145 , A61K9/19 , A61K47/183 , A61K47/26 , A61K2039/525 , A61K2039/55505 , A61K2039/70 , C12N7/00 , C12N2710/20034 , C12N2710/20071 , Y02A50/386
摘要： This present invention relates to compositions and methods for stabilizing a dried vaccine formulations. In particular, the invention provides a method for producing a vaccine composition comprising the steps of providing an aqueous composition comprising a buffer, the vaccine components and between 17.5% w/w and 60% w/w of a non-polymeric sugar, freezing the composition, and applying microwave radiation under a pressure lower than atmospheric pressure in order to sublimate the composition and obtain a dried vaccine formulation. The invention also provides a product obtainable by this method.
摘要翻译： 本发明涉及稳定干燥疫苗制剂的组合物和方法。 特别地，本发明提供了一种用于生产疫苗组合物的方法，其包括以下步骤：提供包含缓冲液，疫苗组分和17.5％w / w至60％w / w的非聚糖之类的水性组合物， 组合物，并在低于大气压的压力下施加微波辐射以使组合物升华并获得干燥的疫苗制剂。 本发明还提供可通过该方法获得的产品。
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公开(公告)号：US10429129B2
公开(公告)日：2019-10-01
申请号：US15029062
申请日：2014-10-13
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：US10369213B2
公开(公告)日：2019-08-06
申请号：US15029064
申请日：2014-10-13
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.
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公开(公告)号：US10350289B2
公开(公告)日：2019-07-16
申请号：US14916458
申请日：2014-09-02
IPC分类号： A61K39/165 , C12N7/00 , A61K39/25 , A61K39/12 , A61K39/05 , A61K39/08 , A61K39/02 , A61K39/102 , A61K39/13 , A61K39/145 , A61K39/20 , A61K39/00
摘要： The present invention relates to a method of vaccinating a patient against varicella zoster virus (VZV) by delivery of an effective amount of a live attenuated VZV vaccine to the epidermis or the dermis of a patient's skin at a depth of between about 100 and about 700 microns from the surface of the skin, which is useful for preventing herpes zoster or reducing the severity or duration thereof. In embodiments of the invention, the patient is 50 years of age or older and has been previously exposed to VZV. The invention also relates to a method of preventing VZV infection in an individual who was not previously infected with VZV comprising administering an effective amount of a live attenuated VZV vaccine to the epidermis or the dermis of the individual's skin at a depth of between about 100 and about 700 microns from the surface of the skin.
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公开(公告)号：US09782470B2
公开(公告)日：2017-10-10
申请号：US15029060
申请日：2014-10-13
CPC分类号： A61K39/12 , A61K9/0019 , A61K9/145 , A61K9/19 , A61K47/183 , A61K47/26 , A61K2039/525 , A61K2039/55505 , A61K2039/70 , C12N7/00 , C12N2710/20034 , C12N2710/20071 , Y02A50/386
摘要： This present invention relates to compositions and methods for stabilizing a dried vaccine formulations. In particular, the invention provides a method for producing a vaccine composition comprising the steps of providing an aqueous composition comprising a buffer, the vaccine components and between 17.5% w/w and 60% w/w of a non-polymeric sugar, freezing the composition, and applying microwave radiation under a pressure lower than atmospheric pressure in order to sublimate the composition and obtain a dried vaccine formulation. The invention also provides a product obtainable by this method.
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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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