Asahi Kasei Pharma Corporation has signed an agreement with AGC Biologics to produce clinical drug substance for antibody-based therapies at Asahi's Seattle manufacturing site.
Under the agreement, AGC Biologics will leverage Asahi's monoclonal antibody development and manufacturing experience to perform process transfer, process optimisation, and clinical manufacturing of the Asahi Kasei Pharma drug substance.
During this clinical phase, scientists at Asahi's Seattle manufacturing site will work to support process optimisation, including product qualification, process development, analytical, and regulatory document support to manufacture the product and prepare it for late phase steps.
The site also recently expanded to add a new microbial-based manufacturing line system
“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 for 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 centre 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.