公开(公告)号：US20140302589A1

公开(公告)日：2014-10-09

申请号：US14291612

申请日：2014-05-30

Applicant: Barofold, Inc.

Inventor： Matthew Seefeldt ,  Eliana Gomez

IPC: C07K1/14 ,  C07K14/555 ,  C12N9/50 ,  C07K14/54

CPC classification number: C07K1/14 ,  C07K1/1136 ,  C07K1/145 ,  C07K14/54 ,  C07K14/555 ,  C12N9/506 ,  C12P21/02

Abstract: The invention provides methods and systems for production of recombinant protein, and particularly, for production of recombinant protein from inclusion bodies. For example, in one aspect, the method comprises providing a protein preparation comprising inclusion bodies, preparing an inclusion body dispersion, and exposing the protein preparation to high pressure in a pressure vessel, to disaggregate and refold the inclusion body protein.

Abstract translation: 本发明提供了用于生产重组蛋白的方法和系统，特别是用于从包涵体生产重组蛋白。 例如，一方面，该方法包括提供包含包含体的蛋白质制备物，制备包涵体分散体，并将蛋白质制剂暴露于高压力的压力容器中，以分解和重折叠包涵体蛋白质。

公开(公告)号：US20150183876A1

公开(公告)日：2015-07-02

申请号：US14323776

申请日：2014-07-03

Applicant: BAROFOLD, INC.

Inventor： Matthew B. Seefeldt ,  Robert Nelson ,  Theodore W. Randolph ,  Lyndal K. Hesterberg

IPC: C07K16/28 ,  C07K1/113 ,  C07K14/705

CPC classification number: C07K16/2827 ,  C07K1/113 ,  C07K1/1136 ,  C07K14/70521 ,  C07K2319/30 ,  C07K2319/33

Abstract: Methods for refolding antibodies, particularly monoclonal antibodies, from aggregated and/or denatured preparations by subjecting the antibody preparation to high hydrostatic pressure are provided. Refolded preparations of antibodies produced by the methods described herein are also provided.

公开(公告)号：US20190218247A1

公开(公告)日：2019-07-18

申请号：US16103812

申请日：2018-08-14

Applicant: Barofold, Inc.

Inventor： Matthew Seefeldt ,  Eliana Gomez

IPC: C07K1/14 ,  C12N9/50 ,  C07K14/555 ,  C12P21/02 ,  C07K14/54

CPC classification number: C07K1/14 ,  C07K1/1136 ,  C07K1/145 ,  C07K14/54 ,  C07K14/555 ,  C12N9/506 ,  C12P21/02

Abstract: The invention provides methods and systems for production of recombinant protein, and particularly, for production of recombinant protein from inclusion bodies. For example, in one aspect, the method comprises providing a protein preparation comprising inclusion bodies, preparing an inclusion body dispersion, and exposing the protein preparation to high pressure in a pressure vessel, to disaggregate and refold the inclusion body protein.

公开(公告)号：US20160002285A1

公开(公告)日：2016-01-07

申请号：US14187055

申请日：2014-02-21

Applicant: Barofold, Inc. ,  The Regents of the University of Colorado, A Body Corporate

Inventor： Matthew B. Seefeldt ,  Theodore W. Randolph ,  Amber Haynes Fradkin ,  John F. Carpenter

IPC: C07K1/02 ,  C07K14/61 ,  C07K14/565 ,  C07K16/24

CPC classification number: C07K1/02 ,  A61K38/215 ,  A61K38/27 ,  C07K1/14 ,  C07K14/565 ,  C07K14/61 ,  C07K16/00 ,  C07K16/241 ,  C07K16/26 ,  C07K2317/14 ,  C07K2317/21

Abstract: The present invention provides methods for reducing and/or evaluating the immunogenic potential of a therapeutic protein preparation. The present invention further provides pharmaceutical compositions of therapeutic proteins and methods of treatment with the same, the compositions having low immunogenic potential and/or improved efficacy. The invention achieves these goals by evaluating therapeutic protein preparations for subvisible protein particulates, which can contribute significantly to the overall immunogenic potential of the protein preparation. Further, by maintaining the content of such subvisible protein particulates to below an immunogenic threshold level, the resulting pharmaceutical composition is less likely to result in a loss of tolerance (e.g., upon repeated administration), thereby improving both the safety and efficacy profile of the therapeutic.

Abstract translation: 本发明提供了用于减少和/或评估治疗性蛋白质制剂的免疫原性潜力的方法。 本发明还提供了治疗性蛋白质的药物组合物及其治疗方法，所述组合物具有低免疫原性潜力和/或改善的功效。 本发明通过评估可见蛋白质颗粒的治疗性蛋白质制剂来实现这些目标，其可以显着地有助于蛋白质制备的整体免疫原性潜力。 此外，通过将这种可隐性蛋白质颗粒的含量维持在免疫原性阈值水平以下，所得到的药物组合物不太可能导致耐受性的丧失（例如，在重复施用时），从而改善了安全性和功效性 治疗。