BioFactura, Inc.


BioFactura, Inc., based in Frederick, Maryland, is a biopharmaceutical company specializing in the development and commercialization of high-value biosimilars, biodefense medical countermeasures, and novel drugs. Leveraging its proprietary StableFast™ Biomanufacturing Platform, BioFactura delivers faster, lower-cost, and superior-quality biologics. With over a decade of experience, the company has advanced life-saving medicines from research to patient care, focusing on unmet global biomedical and national biodefense needs. Its portfolio includes drugs for smallpox, Ebola, cancer, autoimmune, and infectious diseases.

BioFactura, Inc.

BioFactura, Inc.


Patents

Methods of manufacturing therapeutic proteins

2020-09-15 • US-10774353-B2

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Compositions and methods for metabolic selection of transfected cells

2011-12-13 • US-8076102-B2

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What We Do

A proprietary NS0-based system for rapid generation of stable cell lines, enabling lower-cost, high-quality, and single-use compatible manufacturing of biosimilars and novel biologics.

A biosimilar to Stelara® (ustekinumab), developed for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. Undergoing global clinical development and licensed for commercialization in major markets.

A monoclonal antibody-based therapeutic developed as a medical countermeasure for smallpox, supported by significant BARDA contracts for advanced development and clinical trials.

A monoclonal antibody therapeutic for Marburg virus, developed under a Department of Defense SBIR contract to address biothreats and fill gaps in available treatments.

BioFactura offers bioprocess development, scale-up, and manufacturing services for the biopharmaceutical industry, grounded in extensive experience and innovative technology.


Regenerative Medicine

Digital Health Technologies


Key People

President and Chief Executive Officer

Chairman of the Board and Chief Medical Officer

Director and Co-founder

Director, Co-founder and Consultant

VP Scientific Affairs

LinkedIn

News & Updates

BioFactura received a major contract from BARDA for the advanced development of its Smallpox Biodefense Therapeutic.

BioFactura was issued new patents in the US and EU for technologies improving the productivity of its StableFast™ Biomanufacturing Platform.

BioFactura was granted patent rights by China’s SIPO for its StableFast™ Biomanufacturing Platform, expanding market exclusivity in China.

BioFactura was recognized at the inaugural Frederick Real Estate Dealmakers (FRED) Awards for its impact on Frederick County’s economy.

Results from the first-in-human trial comparing pharmacokinetic profiles, safety, and immunogenicity of BFI-751 and ustekinumab reference products.

A study presenting a marmoset model of monkeypox and smallpox disease and the benefits of prophylactic antibody treatment.

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