Generation of Stable Eukaryotic Cell Lines Expressing High Yields of Therapeutic Human Antibodies Against Biowarfare Viral Threat Agents

The generation, characterization, and optimization of stable mammalian cell lines for large-scale antibody production comprise an intricate process that costs millions of dollars and requires nearly one year of development time. When standard methods are employed, the process of generating stable cell lines requires nearly 6 months; however, BioFactura's proven proprietary technologies can routinely reduce the cell line generation timeline to 2 - 2.5 months. In addition, the downstream cell line development process is reduced since the lines are, from the onset, adapted to serum free medium formulations. Therefore, production of clinical quality material can be achieved in less than 7 months and research material in as little as 3 months, while ensuring quality and regulatory compliance. BioFactura has established a collaboration with USAMRIID, and specifically with Dr. Guttieri, as a basis for attaining proof of concept on existing technologies that generate monoclonal antibodies (mAbs) with prophylactic and therpeutic value against viral biowarfare agents, and to build a platform upon which to seek funding through the DoD's SBIR and STTR programs. In this regard, BioFactura's objectives provide a unique opportunity for Dr. Guttieri to expedite production and in vivo analyses of mAbs identified as candidates for future clinical studies that evaluation the efficacy of these antibodies against viruses with bio-weapon potential.