Cell Therapy Manufacturing Takes Shape Across Asia-Pacific
Cell and gene therapy is accelerating across Asia-Pacific, but manufacturing remains fragmented. Strategic automation, adaptable bioprocessing platforms, stronger supply chains, and workforce development could help therapies scale across diverse markets. The post Cell Therapy Manufacturing Takes Shape Across Asia-Pacific appeared first on GEN - Genetic Engineering and Biotechnology News .
The Asia-Pacific region is seeing rapid growth in cell and gene therapy (CGT) innovation and commercialization, but scaling up manufacturing capabilities requires a tailored approach rather than simply replicating successful models across all markets. Jerry Huang, APAC marketing manager for Terumo Blood and Cell Technologies, emphasizes that the region should be viewed as a collection of complementary ecosystems.
China, Japan, Korea, and Australia each bring unique strengths, from cutting-edge CGT innovation and regenerative medicine research to strong biologics capabilities and established clinical trial infrastructure. However, these differences extend beyond strengths to regulatory requirements, import rules, manufacturing capabilities, and reimbursement environments that can significantly impact CGT manufacturing operations.
The complexity of CGT manufacturing, which often involves multiple operations and system transfers, increases the potential for manual intervention and variability. Additionally, differences in media, reagents, and supply chains further complicate the process, with some imported materials taking up to three months to arrive and fresh-cell logistics posing challenges due to flight schedules and weather risks.
Workforce training requirements and turnover among skilled operators and GMP managers also add to the operational risk. Huang advises that while automation can help reduce some vulnerabilities, it should be implemented thoughtfully, following a thorough understanding of processes rather than replacing them. A key strategy is to integrate fragmented workflows, use automation where appropriate, and maintain a balance between standardization and modularity to adapt to local requirements.
In China, Terumo Blood and Cell Technologies is collaborating with local partners to develop a simplified, integrated, and tailored chimeric antigen receptor (CAR) T-cell manufacturing workflow. The objective is to enhance batch economics, reduce manual steps, and improve overall efficiency while upholding quality standards. Huang concludes that achieving regional scale in CGT manufacturing will depend on approaches designed specifically for the Asia-Pacific's diverse landscape, incorporating standardized manufacturing cores, integrated workflows, digital traceability, resilient supply chains, qualified material alternatives, and a larger workforce trained in good manufacturing practices (GMP).
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