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BioFactura Establishes CDMO Division

Capitol Biologics will provide process development, early-phase clinical manufacturing, and analytical services to emerging biotechnology companies and U.S. government agencies.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

BioFactura, Inc., a clinical-stage biopharmaceutical company focused on biosimilars and biodefense medical countermeasures, has established Capitol Biologics, a new Contract Development and Manufacturing Organization (CDMO) division. This division provides process development, early-phase clinical manufacturing, and analytical services to emerging biotechnology companies and U.S. government agencies.

Located in the BioHealth Capital Region, Capitol Biologics leverages BioFactura’s technical and regulatory experience to support the development of biologics from laboratory to first-in-human studies. The division offers comprehensive services, including cell line development, process optimization, GMP manufacturing, and analytical and quality control capabilities, all compliant with global regulatory standards (FDA, EMA, ICH).

Situated in the Washington, DC metropolitan area within the I-270 Biotech Corridor, Capitol Biologics provides logistical access to pharmaceutical hubs, government facilities, and research institutions. It serves both private-sector biotech companies and public health initiatives focused on national preparedness.

Darryl Sampey, President and CEO, stated, “Transforming the biopharma development engine that BioFactura has built over the past 20 years into a pure-play service organization provides an incomparable value to early-stage ventures and initiatives. The depth of experience, know-how and capability that we have gained saves our clients both time and money that are in many cases existential to their survival and success.”

“Capitol Biologics represents the next evolution of BioFactura’s mission,” added Dr. Jeffrey Hausfeld, M.D., M.B.A., F.A.C.S., Chairman of the Board and Chief Medical Officer of BioFactura. “This new division allows us to share our expertise, infrastructure, and passion for science with the broader biotech community at a critical stage of their growth.”

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