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.
Industries
Nr. of Employees
small (1-50)
Patents
Compositions and methods for metabolic selection of transfected cells
2011-12-13 • US-8076102-B2
View Details
Compositions and methods for metabolic selection of transfected cells
2011-12-13 • US-8076102-B2
View DetailsProducts
Platform for rapid stable cell-line generation
A patented biomanufacturing platform that enables expedited generation and selection of stable mammalian cell lines using multiplex selection strategies to improve productivity for biologic production.
Ustekinumab biosimilar candidate (monoclonal antibody)
A clinical-stage biosimilar candidate to ustekinumab developed as a monoclonal antibody for inflammatory and autoimmune indications; progressed through a randomized Phase I PK/bioequivalence study assessing PK, safety and immunogenicity.
Monoclonal antibody cocktail for orthopoxvirus therapeutic
An antibody-based therapeutic candidate developed as a cocktail of monoclonal antibodies for treatment of orthopoxvirus infections; demonstrated efficacy in non-human primate models and advanced under government-funded development contracts.
Platform for rapid stable cell-line generation
A patented biomanufacturing platform that enables expedited generation and selection of stable mammalian cell lines using multiplex selection strategies to improve productivity for biologic production.
Ustekinumab biosimilar candidate (monoclonal antibody)
A clinical-stage biosimilar candidate to ustekinumab developed as a monoclonal antibody for inflammatory and autoimmune indications; progressed through a randomized Phase I PK/bioequivalence study assessing PK, safety and immunogenicity.
Monoclonal antibody cocktail for orthopoxvirus therapeutic
An antibody-based therapeutic candidate developed as a cocktail of monoclonal antibodies for treatment of orthopoxvirus infections; demonstrated efficacy in non-human primate models and advanced under government-funded development contracts.
Expertise Areas
- Clinical trial management (Phase I PK/bioequivalence studies)
- Bioprocess development and scale-up
- Mammalian cell-line development
- Monoclonal antibody discovery and development
Key Technologies
- Stable mammalian cell-line generation and multiplex selection
- NS0-based mammalian expression systems
- Mammalian cell culture scale-up
- Single-use bioprocess compatibility
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
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.
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.