We are pleased to announce a fresh collaboration with Asahi Kasei Pharma Corporation aimed at producing clinical drug substance for antibody-based therapies. This venture will take place at our state-of-the-art manufacturing site in Seattle. Within the scope of this agreement, AGC Biologics will utilize its extensive experience in monoclonal antibody development and manufacturing to facilitate process transfer, process optimization, and clinical-level production of the drug substance developed by Asahi Kasei Pharma.

During the clinical phase of this collaboration, our Seattle-based research scientists will actively engage in supporting process enhancement efforts. This will encompass activities such as product qualification, process development, analytical procedures, and regulatory documentation preparation, all geared towards ensuring the successful manufacturing of the product and its readiness for subsequent stages.

JB Agnus, Chief Business Officer at AGC Biologics, commented, "Our company boasts a robust track record in antibody production. We take pride in our ability to offer both technical expertise and flexibility to cater to diverse drug substance requirements during this pivotal clinical phase. We eagerly anticipate partnering with Asahi Kasei Pharma to contribute to the success of this significant project."

At our Seattle facility, AGC Biologics manages multiple mammalian cGMP manufacturing lines, operating at varying scales. This location stands as a center of excellence in formulation and employs cutting-edge fed-batch and perfusion manufacturing techniques. Notably, the site recently expanded its capabilities by incorporating a new microbial-based manufacturing line system. With a three-decade history in biologics production, we have consistently earned successful assessments from the Food and Drug Administration (FDA). Our production expertise spans all project phases, ranging from pre-clinical stages to full-scale commercial production.

For further insights into our biologics manufacturing hub in Seattle, please visit www.agcbio.com/facilities/seattle. To delve deeper into our array of services encompassing Protein Biologics, Plasmid DNA (pDNA), Cell Therapy, Viral Vector, and Messenger RNA (mRNA) drug products, we invite you to explore www.agcbio.com."