AGC Biologics Partners with Asahi Kasei Pharma Corporation on Clinical Antibody Project

  • AGC Biologics has entered into an agreement with Asahi Kasei Pharma Corporation to produce clinical drug substances for antibody-based therapies at AGC’s Seattle manufacturing site. AGC will utilize its expertise to perform process transfer, optimization, and clinical manufacturing of the drug substance.
  • AGC Biologics’ Seattle facility, equipped with multiple mammalian cGMP manufacturing lines, will support process optimization, formulation, and employ various manufacturing processes. The site’s expansion includes a new microbial-based manufacturing line system, showcasing AGC’s extensive experience in biologics production across pre-clinical to commercial phases.


Article Summary 

AGC Biologics has unveiled a significant collaboration with Asahi Kasei Pharma Corporation aimed at the production of clinical drug substance for antibody-based therapies. The partnership will be executed at AGC’s cutting-edge manufacturing facility located in Seattle. This strategic agreement underscores AGC’s commitment to leveraging its extensive experience in monoclonal antibody development and manufacturing to support Asahi Kasei Pharma in this critical clinical phase.

The collaboration entails a comprehensive scope, including process transfer, process optimization, and the crucial task of clinical manufacturing for the drug substance developed by Asahi Kasei Pharma. AGC’s seasoned scientists at the Seattle site will engage in intricate process optimization efforts, encompassing product qualification, process development, analytical work, and regulatory document support. These multifaceted activities are designed to ensure the seamless preparation of the drug substance for subsequent late-phase processes.

JB Agnus, Chief Business Officer at AGC Biologics, emphasized the company’s rich history in antibody production and its commitment to providing technical expertise to meet the unique drug substance needs during this pivotal clinical stage. The collaboration with Asahi Kasei Pharma is poised to not only showcase AGC’s proficiency but also to contribute substantially to the success of Asahi Kasei Pharma’s significant project.

AGC Biologics’ Seattle manufacturing facility stands as a center of excellence for formulation and boasts several mammalian cGMP manufacturing lines operating at varying scales. The facility’s capabilities extend to the implementation of advanced fed-batch and perfusion manufacturing processes. Notably, the site recently expanded to include a state-of-the-art microbial-based manufacturing line system, further enhancing AGC’s biologics production capabilities.

With a remarkable 30-year track record in producing biologics products and a history of successful inspections by the Food and Drug Administration (FDA), AGC Biologics has demonstrated its prowess in catering to projects across all phases, from pre-clinical stages to full-scale commercial production. This collaboration with Asahi Kasei Pharma aligns with AGC’s mission to advance biopharmaceutical solutions and underscores its status as a reliable partner in the evolving landscape of drug development and manufacturing.

Source: AGC Biologics, 15th August 2023