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The agreement also lists that AGC Biologics will leverage the company’s monoclonal antibody development and manufacturing experience to perform process transfer, process optimization, and clinical manufacturing of the Asahi Kasei drug substance.
AGC Biologics announced a new agreement with Asahi Kasei Pharma Corporation on Aug. 15, 2023 to produce clinical drug substance for antibody-based therapies for Asahi Kasei at the AGC Biologics’ Seattle manufacturing site. The agreement also lists that AGC Biologics will leverage the company’s monoclonal antibody development and manufacturing experience to perform process transfer, process optimization, and clinical manufacturing of the Asahi Kasei drug substance, according to the press release.
The Seattle location features multiple mammalian current good manufacturing practice manufacturing lines at various scales and serves as a center of excellence for formulation. A recent expansion added a new microbial-based manufacturing line system. The scientists at the Seattle manufacturing site are planning to support process optimization during the clinical phase, including product qualification, process development, analytical, and regulatory document to further support the manufacture of the product for late-phase preparation.
“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, in a press release. “We look forward to partnering with Asahi Kasei Pharma to help achieve their goals with this important project.”
The Seattle facility serves as a hub for formulation and can provide the latest fed-batch and perfusion manufacturing processes. It also recently expanded with new microbial-based manufacturing line system, according to the press release.
Source: AGC Biologics