Cell and gene therapy manufacturers deploying in Asia-Pacific should budget six to nine months of training before a new CGT operator reaches required proficiency — one of several concrete constraints Jerry Huang of Terumo Blood and Cell Technologies lays out in a new assessment of the region's manufacturing readiness. His message to R&D and portfolio planners is blunt: a single centralized plant will not serve the region.

Huang, APAC marketing manager for cell therapy technologies at Terumo Blood and Cell Technologies, argues the region functions as four distinct ecosystems, not one market.

• China runs a fast-growing CGT innovation and commercialization ecosystem.
• Japan holds particular strength in induced pluripotent stem cells and regenerative medicine.
• Korea combines biologics capability with contract development and manufacturing organization capacity.
• Australia offers established clinical-trial infrastructure.

"APAC is better viewed as a collection of complementary ecosystems rather than one uniform market," Huang says. Developers "cannot assume that a single, centralized manufacturing site will efficiently serve every Asian market," he adds, citing different regulatory requirements, import rules, manufacturing capabilities and reimbursement environments country by country.

What does this mean for bioprocessing teams?

The differences translate directly into workflow and budget exposure. CGT manufacturing involves many individual operations and transfers between systems, multiplying opportunities for manual intervention and variability. Media and reagents differ in availability and regulatory acceptability across borders, complicating technology transfer and localization.

Supply chains add measurable delays. Customer feedback from Thailand, according to Huang, shows some imported materials "can take up to three months to arrive" — a figure that pushes inventory planning and supplier agreements into the scope of good manufacturing practice (GMP) operations rather than leaving them to procurement alone.

Fresh-cell logistics carry their own schedule risk. Huang points to shipping from Taiwan to U.S. clinical sites, where "flight schedules and even typhoon risk need to be factored into manufacturing planning."

Workforce is the third constraint. Beyond the six-to-nine-month training period for proficiency, turnover among skilled operators and senior GMP managers adds operational risk that portfolio timelines should absorb.

Where does automation fit?

Huang resists automation-first thinking. Automation, he argues, should follow process understanding, not substitute for it. The priority 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."

Terumo is applying that logic in China, working with local partners to build a simplified, integrated, fit-for-purpose 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 stated goals are to "simplify the workflow, reduce manual steps and operational complexity, and improve batch economics" while preserving the consistency and scalability that clinical and commercial manufacturing demand.

Notably, these claims come from a vendor executive describing his company's own partnership strategy, not from independent benchmarking — the batch-economics improvements in the China CAR-T project are targets rather than measured results, and no timeline or sample data accompanies them.

What would regional scale require?

Huang's closing prescription: manufacturing approaches "designed for the region's diversity rather than attempting a single model and trying to make it work everywhere." He lists the enabling elements as standardized manufacturing cores, more integrated workflows, digital traceability, resilient supply chains, qualified material alternatives, and a larger GMP-trained workforce.

For R&D managers weighing APAC capacity decisions, the practical takeaway is a checklist, not a slogan: build a standardized core workflow, keep modular adaptation for each market's regulatory and materials reality, and treat supplier lead times and staff training curves as line items in any capacity plan. Whether Terumo's China CAR-T workflow delivers measurable batch-economics gains will be the test case to watch.