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Process Development and Manufacture of an Antibody-based Therapy Against Marburgvirus

Award Information
Agency: Department of Defense
Branch: Office for Chemical and Biological Defense
Contract: HDTRA1-20-C-0033
Agency Tracking Number: C2-0535
Amount: $481,675.14
Phase: Phase II
Program: SBIR
Solicitation Topic Code: CBD171-005
Solicitation Number: 17.1
Timeline
Solicitation Year: 2017
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-06-15
Award End Date (Contract End Date): 2022-06-14
Small Business Information
8435 Progress Dr Ste Z
Frederick, MD 21701
United States
DUNS: 168920143
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 Darryl Sampey
 President and CEO
 (240) 620-3566
 dsampey@biofactura.com
Business Contact
 Darryl Sampey
Phone: (240) 620-3566
Email: dsampey@biofactura.com
Research Institution
N/A
Abstract

The Phase II strategy proposed provides for the development and optimization of a feasible, rapidly scalable, single-use manufacturing platform for the production of a mAb directed against Marburgvirus. Application of BioFactura’s StableFast patented manufacturing platform will result in an economically-produced mAb therapeutic with consistent, targeted properties for safety and efficacy. Characterization of both the product and process in accordance with Phase I clinical requirements will be performed as well as the identification of high-risk parameters at commercial scale. In-process and release assays will be qualified for these purposes. The intimate process knowledge gained throughout these experimentation and intensification efforts can be directly funneled back into the improvement of clinical manufacturing activities during SBIR Phase III continuation.

* Information listed above is at the time of submission. *

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