Cell and gene therapy (CGT) is gathering momentum across the Asia-Pacific region (APAC), but translating that growth into scalable manufacturing will require more than simply moving established processes into new markets. The challenge is that the region cannot be treated as a single manufacturing environment.
“APAC is better viewed as a collection of complementary ecosystems rather than one uniform market,” says Jerry Huang, APAC marketing manager, cell therapy technologies for Terumo Blood and Cell Technologies. China has a fast-growing CGT innovation and commercialization ecosystem, while Japan brings particular strength in induced pluripotent stem cells and regenerative medicine. Korea combines strong biologics and contract development and manufacturing organization capabilities, and Australia offers an established clinical-trial infrastructure.
Those strengths are accompanied by significant manufacturing differences. “Each country can have different regulatory requirements, import rules, manufacturing capabilities, and reimbursement environments,” Huang says. As a result, he adds, developers “cannot assume that a single, centralized manufacturing site will efficiently serve every Asian market.”
For bioprocessing teams, those differences quickly become practical concerns. CGT manufacturing can involve many individual operations and transfers between systems, creating more opportunities for manual intervention and variability. Media and reagents may also differ in availability and regulatory acceptability from one country to another, complicating technology transfer and localization.
Supply chains can compound the problem. According to feedback from customers in Thailand, Huang says, “some imported materials can take up to three months to arrive,” which makes inventory planning and supplier agreements part of good manufacturing practice (GMP) operations. Fresh-cell logistics can be equally demanding. He points to an example of shipping from Taiwan to U.S. clinical sites, where “flight schedules and even typhoon risk need to be factored into manufacturing planning.”
Workforce constraints add another layer of complexity. In some organizations, CGT manufacturing personnel can require six to nine months of training for required proficiency, while turnover among skilled operators and senior GMP managers can introduce additional operational risk.
Automation could reduce some of those vulnerabilities, but Huang argues that it should follow process understanding, not substitute for it. Here, Huang points out that the most crucial issue is “simplifying and integrating fragmented workflows, while using automation where it adds value and balancing a standardized core workflow with modularity and adaptability for different pipelines, process needs, and local requirements.”
In China, for example, Terumo Blood and Cell Technologies is working with local partners to build a more simplified, integrated, and fit-for-purpose chimeric antigen receptor (CAR) T-cell manufacturing workflow. “The idea is not to replace local technologies,” Huang says, “but to bring together each partner’s strengths with our global manufacturing experience and quality standards.” The goal, he adds, is to “simplify the workflow, reduce manual steps and operational complexity, and improve batch economics” while maintaining the consistency and scalability required for clinical and commercial manufacturing.
Ultimately, Huang sees regional scale depending on manufacturing approaches “designed for the region’s diversity rather than attempting a single model and trying to make it work everywhere.” Standardized manufacturing cores, more integrated workflows, digital traceability, resilient supply chains, qualified material alternatives, and a larger GMP-trained workforce could all help turn Asia-Pacific’s diverse CGT ecosystems into a more connected manufacturing landscape.