SEATTLE--(BUSINESS WIRE)--AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced a new agreement with Asahi Kasei Pharma Corporation to produce clinical drug substance for antibody-based therapies at AGC Biologics’ Seattle manufacturing site.
Under the agreement, AGC Biologics will leverage its monoclonal antibody development and manufacturing experience to perform process transfer, process optimization, and clinical manufacturing of the Asahi Kasei Pharma drug substance.
During this clinical phase, scientists at the Seattle manufacturing site will work to support process optimization, including product qualification, process development, analytical, and regulatory document support to manufacture the product and prepare it for late phase steps.
“Our company has a strong history of antibody production, and we pride ourselves on offering the flexibility and the technical expertise to meet any drug substance need at this critical clinical phase,” said JB Agnus, Chief Business Officer, AGC Biologics. “We look forward to partnering with Asahi Kasei Pharma to help achieve their goals with this important project.”
AGC Biologics runs multiple mammalian cGMP manufacturing lines at various scales at its Seattle facility. The campus serves as a center of excellence for formulation and employs the latest fed-batch and perfusion manufacturing processes.
The site also recently expanded to add a new microbial-based manufacturing line system. The AGC Biologics Seattle campus has produced biologics products for 30 years, has a long history of successful inspections by the Food and Drug Administration (FDA) and a successful history of production for projects at all phases, from pre-clinical through commercial production.
To learn more about AGC Biologics’ biologics manufacturing site in Seattle, visit www.agcbio.com/facilities/seattle. For more information on the company’s Protein Biologics, Plasmid DNA (pDNA), Cell Therapy, Viral Vector and Messenger RNA (mRNA) drug product services visit www.agcbio.com.
About AGC Biologics
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan and we currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.
