Biologics Manufacturing
Capabilities
BioFactura offers an wide array of preclinical (non-cGMP) manufacturing for biomolecules. We specialize in mammalian cell culture-based processes with an emphasis on the production of monoclonal antibodies. We also offer manufacturing services for bacterial and yeast derived products as well as specialty biologics such as polysaccharides. Our upstream bioreactor/fermentor capacity is currently 5 liters.
BioFactura Quality System
BioFactura has implemented a series of quality controls based on the FDA’s Guidance for Industry - Phase 1 GMP and ICH Q5D, Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products. Our technical and scientific activities are governed by SOP and fully documented. We have full traceability of cell substrates, media, buffers, reagents, and critical supplies used in the development of client products. Our equipment and instruments are routinely calibrated by qualified service providers and calibration, cleaning and preventive maintenance are documented. Employee training is conducted regularly, in group or individual settings, and is fully documented.