BioFactura, Inc.
BioFactura develops and manufactures high-value biosimilars, biodefense medical countermeasures, and client-selected novel drugs. Using its patented StableFast Biomanufacturing Platform, it aims to bring these drugs to market faster, at lower cost, and with superior quality. The company has over 10 years of experience in advancing medicines from research to patient care, including programs against smallpox, Ebola, cancer, and infectious diseases.
Industries
Nr. of Employees
small (1-50)
BioFactura, Inc.
Patents
Products
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.
Services
Process development, optimization and scale-up for mammalian cell-culture biologics, compatible with single-use systems and intended for clinical manufacture.
Contract R&D services including cell line development, platform application, recombinant protein expression and early-stage product development.
Design and execution of in vivo efficacy testing using disease-relevant animal models to support therapeutic selection and IND-enabling packages.
Management and execution of early-phase clinical trials including randomized PK/bioequivalence studies, safety and immunogenicity assessments.
Structuring of exclusive and non-exclusive licensing agreements, technology transfer and partnership arrangements to enable global manufacturing and commercialization.
Process development, optimization and scale-up for mammalian cell-culture biologics, compatible with single-use systems and intended for clinical manufacture.
Contract R&D services including cell line development, platform application, recombinant protein expression and early-stage product development.
Design and execution of in vivo efficacy testing using disease-relevant animal models to support therapeutic selection and IND-enabling packages.
Management and execution of early-phase clinical trials including randomized PK/bioequivalence studies, safety and immunogenicity assessments.
Structuring of exclusive and non-exclusive licensing agreements, technology transfer and partnership arrangements to enable global manufacturing and commercialization.
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
News & Updates
Funding from BARDA to develop a smallpox biodefense therapeutic.
Additional funding from BARDA to advance smallpox therapeutic development.
Publication of pharmacokinetic study results for BFI-751.
Results from a randomized Phase 1 trial comparing BFI-751 to Stelara.
Development of an animal model for monkeypox and smallpox.
BioFactura was granted a patent in the US and EU for its StableFast biomanufacturing platform.
Funding from BARDA to develop a smallpox biodefense therapeutic.
Additional funding from BARDA to advance smallpox therapeutic development.
Publication of pharmacokinetic study results for BFI-751.
Results from a randomized Phase 1 trial comparing BFI-751 to Stelara.
Development of an animal model for monkeypox and smallpox.
BioFactura was granted a patent in the US and EU for its StableFast biomanufacturing platform.