公开(公告)号：US11364293B2

公开(公告)日：2022-06-21

申请号：US16909689

申请日：2020-06-23

Applicant: THE REGENTS OF THE UNIVERSITY OF COLORADO

Inventor： Theodore W. Randolph ,  Robert Garcea ,  Alan W. Weimer

IPC: C12Q1/68 ,  C07H21/04 ,  G01N27/74 ,  A61K47/10 ,  A61K48/00 ,  A61K39/12 ,  A61K9/50 ,  A61K39/02 ,  A61K39/39 ,  A61K39/00

Abstract: Embodiments of the present disclosure provide novel compositions, methods of use and methods for single composition, multi-dose, thermostable vaccine formulations. In certain embodiments, the present disclosure provides compositions and methods for dehydrating immunogenic agents in the presence of glass-forming agents, and coating the particles formed by the glass-forming agents. In other embodiments, the present disclosure provides for generating compositions for administering an immunogenic composition to a subject multiple times using a single immunogenic composition capable of time-release administration. In other embodiments, single-dose immunogenic agent-containing particles can be directed to two or more pathogens. In other embodiments, incompatible immunogenic agents against two or more different pathogens of immunogenic agent-containing particles disclosed herein can be mixed together and coated for timed-release administration to produce single-administration formulations capable of eliciting an immune response to the two or more pathogens in a subject.

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。

公开(公告)号：US20220265810A1

公开(公告)日：2022-08-25

申请号：US17741894

申请日：2022-05-11

Applicant: THE REGENTS OF THE UNIVERSITY OF COLORADO, A BODY CORPORATE

Inventor： Theodore W. Randolph ,  Robert Garcea ,  Alan W. Weimer

IPC: A61K39/12 ,  A61K9/50 ,  A61K39/02 ,  A61K39/39

Abstract: Embodiments of the present disclosure provide novel compositions, methods of use and methods for single composition, multi-dose, thermostable vaccine formulations. In certain embodiments, the present disclosure provides compositions and methods for dehydrating immunogenic agents in the presence of glass-forming agents, and coating the particles formed by the glass-forming agents. In other embodiments, the present disclosure provides for generating compositions for administering an immunogenic composition to a subject multiple times using a single immunogenic composition capable of time-release administration. In other embodiments, single-dose immunogenic agent-containing particles can be directed to two or more pathogens. In other embodiments, incompatible immunogenic agents against two or more different pathogens of immunogenic agent-containing particles disclosed herein can be mixed together and coated for timed-release administration to produce single-administration formulations capable of eliciting an immune response to the two or more pathogens in a subject.

公开(公告)号：US20210303818A1

公开(公告)日：2021-09-30

申请号：US17264690

申请日：2019-07-30

Applicant: The Regents of the University of Colorado, a body Corporate ,  Ursa Analytics, Inc.

Inventor： Theodore W. Randolph ,  Austin Lewis Daniels ,  Christopher P. Calderon

IPC: G06K9/00 ,  G01N15/14 ,  G06N3/04

Abstract: The current invention describes systems, methods and apparatus for the combination of high-throughput flow imaging microscopy coupled with convolutional neural networks to analyze particles, such as aggregated biomolecules, and cells for use in in a variety of diagnostic, therapeutic and industrial applications.

公开(公告)号：US10751408B2

公开(公告)日：2020-08-25

申请号：US16079507

申请日：2017-02-23

Applicant: The Regents of the University of Colorado, a body corporate

Inventor： Theodore W. Randolph ,  Robert Garcea ,  Alan W. Weimer

IPC: G01N27/403 ,  C12Q1/68 ,  G01N27/414 ,  C12M1/34 ,  C12M3/00 ,  A61K39/12 ,  A61K9/50 ,  A61K39/02 ,  A61K39/39 ,  A61K39/00

Abstract: Embodiments of the present disclosure provide novel compositions, methods of use and methods for single composition, multi-dose, thermostable vaccine formulations. In certain embodiments, the present disclosure provides compositions and methods for dehydrating immunogenic agents in the presence of glass-forming agents, and coating the particles formed by the glass-forming agents. In other embodiments, the present disclosure provides for generating compositions for administering an immunogenic composition to a subject multiple times using a single immunogenic composition capable of time-release administration. In other embodiments, single-dose immunogenic agent-containing particles can be directed to two or more pathogens. In other embodiments, incompatible immunogenic agents against two or more different pathogens of immunogenic agent-containing particles disclosed herein can be mixed together and coated for timed-release administration to produce single-administration formulations capable of eliciting an immune response to the two or more pathogens in a subject.

公开(公告)号：US20190046632A1

公开(公告)日：2019-02-14

申请号：US16079507

申请日：2017-02-23

Applicant: The Regents of the University of Colorado, a body Corporate

Inventor： Theodore W. Randolph ,  Robert Garcea ,  Alan W. Weimer

IPC: A61K39/12 ,  A61K9/50 ,  A61K39/02 ,  A61K39/39

CPC classification number: A61K39/12 ,  A61K9/5015 ,  A61K39/02 ,  A61K39/39 ,  A61K2039/55505 ,  A61K2039/55555 ,  A61K2039/60 ,  C12N2710/20034 ,  C12N2770/24134

Abstract: Embodiments of the present disclosure provide novel compositions, methods of use and methods for single composition, multi-dose, thermostable vaccine formulations. In certain embodiments, the present disclosure provides compositions and methods for dehydrating immunogenic agents in the presence of glass-forming agents, and coating the particles formed by the glass-forming agents. In other embodiments, the present disclosure provides for generating compositions for administering an immunogenic composition to a subject multiple times using a single immunogenic composition capable of time-release administration. In other embodiments, single-dose immunogenic agent-containing particles can be directed to two or more pathogens. In other embodiments, incompatible immunogenic agents against two or more different pathogens of immunogenic agent-containing particles disclosed herein can be mixed together and coated for timed-release administration to produce single-administration formulations capable of eliciting an immune response to the two or more pathogens in a subject.

公开(公告)号：US20250131749A1

公开(公告)日：2025-04-24

申请号：US18701601

申请日：2022-10-15

Applicant: The Regents of the University of Colorado, a body corporate

Inventor： Hannah R. Middlestead ,  Theodore W. Randolph ,  Christopher Calderon

IPC: G06V20/69 ,  C12M1/00 ,  C12M1/34 ,  G06V10/25 ,  G06V10/80 ,  G06V10/82

Abstract: The invention includes systems and methods to combine acoustic sorting, high-throughput imaging technology and machine learning, such as convolutional neural networks (ConvNet) analysis, to analyze cells, pathogens, and other target particles from biological samples resolvable by high-throughput imaging microscopy, or other comparable instrument.

公开(公告)号：US12186384B2

公开(公告)日：2025-01-07

申请号：US17741894

申请日：2022-05-11

Applicant: THE REGENTS OF THE UNIVERSITY OF COLORADO, A BODY CORPORATE

Inventor： Theodore W. Randolph ,  Robert Garcea ,  Alan W. Weimer

IPC: A61K39/12 ,  A61K9/19 ,  A61K9/50 ,  A61K39/00 ,  A61K39/02 ,  A61K39/39 ,  A61K48/00

Abstract: Embodiments of the present disclosure provide novel compositions, methods of use and methods for single composition, multi-dose, thermostable vaccine formulations. In certain embodiments, the present disclosure provides compositions and methods for dehydrating immunogenic agents in the presence of glass-forming agents, and coating the particles formed by the glass-forming agents. In other embodiments, the present disclosure provides for generating compositions for administering an immunogenic composition to a subject multiple times using a single immunogenic composition capable of time-release administration. In other embodiments, single-dose immunogenic agent-containing particles can be directed to two or more pathogens. In other embodiments, incompatible immunogenic agents against two or more different pathogens of immunogenic agent-containing particles disclosed herein can be mixed together and coated for timed-release administration to produce single-administration formulations capable of eliciting an immune response to the two or more pathogens in a subject.