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.
Patents
Compositions and methods for metabolic selection of transfected cells
2011-12-13 • US-8076102-B2
View DetailsWhat 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.
Application Area
Regenerative Medicine
Biologics
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
Director
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.
Research on improving biosimilar monoclonal antibody expression using BioFactura’s NS0 platform.
Discussion of scientific challenges in developing industry standards for regulatory approval of biosimilar monoclonal antibodies.
Study on Lassa virus glycoprotein complex and implications for GP1 ectodomain shedding.
Research on bacterial-based systems for expressing and purifying Lassa virus proteins.
BioFactura announced contract option activations totaling $7.8 million by BARDA as part of its prime contract for the advanced development of its Smallpox Biodefense Therapeutic.
BioFactura announced a contract option activation of over $16 million by BARDA to support ongoing product development and clinical manufacturing for its Smallpox Biodefense Therapeutic.
BioFactura published results from a pivotal Phase 1 study for BFI-751, demonstrating bioequivalence to Stelara and paving the way for global Phase 3 trials.
CuraTeQ Biologics entered into an exclusive license to commercialize BFI-751, BioFactura’s biosimilar to Stelara, in major global markets.
BioFactura announced a $15.9 million contract option activation from BARDA to advance development of an antibody cocktail therapeutic for smallpox.
BioFactura entered an agreement with Rani Therapeutics to assess its Ustekinumab Biosimilar (BFI-751) in combination with Rani’s RaniPill™ platform.
BioFactura initiated a pivotal Phase 1 clinical trial for its Ustekinumab Biosimilar (BFI-751) to assess pharmacokinetics, safety, and immunogenicity.
BioFactura announced a contract option activation of over $13 million by BARDA for the advanced development of its smallpox biodefense therapeutic.
BioFactura was awarded a $1 million SBIR Phase II contract by the Department of Defense to develop a monoclonal antibody therapeutic for Marburg virus.
Patents covering novel technologies that improve productivity and efficiency of the StableFast™ Biomanufacturing Platform.
Patent rights granted by China’s SIPO protecting the core technologies of the StableFast™ Biomanufacturing Platform.