Under the agreement, AGC Biologics will leverage our monoclonal antibody development and manufacturing experience to perform process transfer, process optimization, and clinical manufacturing of the Asahi Kasei Pharma drug substance
AGC Biologics runs multiple mammalian cGMP manufacturing lines at various scales at our Seattle facility. (Credit: AGC Biologics)
Today, we announced a new agreement with Asahi Kasei Pharma Corporation to produce clinical drug substance for antibody-based therapies at our Seattle manufacturing site. Under the agreement, AGC Biologics will leverage our 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 our 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 our 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. We have produced biologics products for 30 years, with 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.
Source: Company Press Release