ASEAN is entering a new phase of biopharmaceutical manufacturing, where simply building more capacity will no longer guarantee competitiveness. As product pipelines become more complex and demand increasingly unpredictable, the advantage is shifting towards manufacturers that can adapt facilities, transfer technologies and scale production with speed and confidence.

In an interaction with Biopharma APAC, Serena Choo, Bioprocess and Genomic Medicine Sales Director, ASEAN, Cytiva, discusses how modular facilities, single-use technologies and digital manufacturing are reshaping the region’s bioprocessing landscape—and why building a connected yet locally tailored manufacturing strategy could define ASEAN’s next chapter of biopharma growth.

As ASEAN’s biopharmaceutical sector continues to expand, why is manufacturing agility becoming a greater competitive advantage than simply increasing production capacity?

For therapeutic manufacturers, capacity remains important. However, in today’s biopharmaceutical environment, it is no longer the only differentiator. In ASEAN, the real advantage lies in the ability to respond quickly when demand shifts, new modalities enter the pipeline, or manufacturing needs to move closer to patients and markets.

Agility is defined by the flexibility to switch between production campaigns with shorter turnaround times, reducing batch-to-batch changeover times, or takt time. For manufacturers, this means agility must be designed into the operating model rather than added later. It requires earlier alignment across process development, manufacturing, quality, engineering, supply chain, service, and demand planning teams so that decisions can be made faster and execution risks can be minimized. Multi-modality facilities are also becoming increasingly common as regulatory guidance and frameworks continue to evolve.

The companies that succeed will not simply be those with the largest manufacturing assets. They will be the ones that can make confident decisions earlier, adapt their manufacturing models with minimal disruption, and scale in a disciplined manner as market needs evolve.

Demand for biologics, vaccines and advanced therapies remains difficult to predict. How can manufacturers design facilities and production strategies that are flexible enough to respond to changing market dynamics while remaining cost-effective?

Manufacturers need to start with a facility strategy that gives them options. Demand for biologics, vaccines, and advanced therapies can shift quickly, so facilities should be designed to expand, adapt, or be reconfigured without creating unnecessary complexity or stranded capacity. This is why more companies are considering modular designs, phased investments, and single-use technologies where they make sense. These approaches allow manufacturers to build for current demand while maintaining the flexibility to adjust as market requirements evolve and product pipelines become clearer. Sanofi’s Modulus facility in Singapore is a strong example of this shift. Its modular design is intended to support multiple vaccines and biopharmaceutical products, while enabling faster changeovers compared to conventional facilities.

Cost-effectiveness should also be evaluated across the full lifecycle of a facility, not solely through upfront capital expenditure. A more flexible design may require greater planning and investment at the outset, but it can help manufacturers avoid underutilized capacity, costly redesigns, and delays when market needs change.

Single-use technologies, modular facilities and digital manufacturing are reshaping bioprocessing. Which innovations will have the greatest impact on improving manufacturing agility across ASEAN over the next five years?

Over the next five years, I believe digitalisation will become one of the most significant enablers of manufacturing agility, particularly as ASEAN expands into more complex biologics and advanced modalities. Single-use technologies and modular facilities will continue to provide the physical flexibility manufacturers need, but digital manufacturing brings a different layer of value. It provides greater visibility into process performance, equipment utilisation, quality trends, and operational risk, enabling teams to make faster decisions and improve consistency as they scale operations. 

This is especially relevant for ASEAN because the region is not only adding manufacturing capacity; it is also moving into higher-value and more technically demanding production. As product portfolios become more complex, the ability to connect data, process knowledge, automation, and workforce capability will become increasingly important. We are also seeing manufacturers in Indonesia adopt single-use manufacturing platforms to accelerate biologics capabilities while maintaining flexibility for future expansion. This reflects a broader regional shift toward practical, scalable technologies that support faster capability building.

AstraZeneca’s planned end-to-end ADC manufacturing facility in Singapore is another indicator of where the industry is heading. Advanced modalities require strong technical expertise, integrated operations, and a high degree of control across the manufacturing process. Digital and automation capabilities will be essential to support this next phase of growth. Ultimately, the greatest impact will come when these technologies are implemented as part of a connected manufacturing strategy rather than as standalone investments. That is how companies can strengthen speed, resilience, and operational effectiveness simultaneously.

Many emerging biopharma companies face the challenge of scaling from clinical to commercial manufacturing. What are the most common mistakes organisations make during this transition, and how can they avoid costly delays?

A common mistake is treating commercial manufacturing as simply a scale-up of the clinical process. In reality, the transition requires a different level of discipline and operational readiness. Companies need to strengthen process robustness, documentation, quality systems, supply continuity, and regulatory preparedness much earlier in the development cycle. When these areas are addressed too late, the result is often rework, delays, and increased costs.

Another frequent challenge is underestimating site readiness during technology transfer. A process that performs well in one location will not automatically perform the same way in another. The receiving site must have the appropriate capabilities, training, infrastructure, and cross-functional ownership to ensure a smooth and successful transfer. We are also seeing greater technology transfer activity from China, India, and Korea into ASEAN markets—for example, from China to Singapore and from Korea to Thailand or Indonesia—as companies seek to expand regional manufacturing capabilities, strengthen supply resilience, and better serve local demand.

The lesson is clear: technology transfer should not be managed as a documentation exercise. It is an execution exercise that requires early alignment across process development, manufacturing, quality, engineering, procurement, supply chain, and demand planning teams. Organizations that establish this alignment early are far better positioned to avoid costly delays and achieve a smoother path to commercialization. 

ASEAN comprises markets with varying levels of manufacturing maturity, regulatory frameworks and infrastructure. How should companies tailor their manufacturing strategies to successfully serve this diverse regional landscape?

ASEAN should not be approached as a single, uniform market. Each country has its own strengths, constraints, and priorities, which means manufacturing strategies need to be tailored rather than replicated across the region.

Singapore continues to play an important role in complex manufacturing, advanced modalities, and the adoption of digital and automation capabilities. It also has a strong track record in managing technology transfers into manufacturing sites. Many facilities are equipped with process development capabilities that enable small-scale proof-of-concept work before progressing to clinical and commercial production. Thailand is building momentum as a biopharmaceutical hub, with investments spanning multiple modalities, including recombinant proteins, vaccines, monoclonal antibodies, and cell and gene therapies. Indonesia remains focused on localization and healthcare self-sufficiency, while Vietnam is strengthening its healthcare and manufacturing base, with growing interest in developing higher-value capabilities.

For companies, the key question is what role each market should play within the broader regional network. Some markets may be best positioned for complex manufacturing and innovation, while others may focus on local access, fill-finish operations, packaging, workforce development, or phased capability building. The most effective approach is to build a connected ASEAN manufacturing strategy—one that is tailored to local market realities while maintaining consistent standards for quality, compliance, and operational excellence across the region.

Looking ahead, what will define a future-ready biomanufacturing organisation in ASEAN, and how is Cytiva helping customers build resilient, scalable and sustainable manufacturing capabilities?

A future-ready biomanufacturing organization in ASEAN will be defined by its resilience, scalability, and execution discipline. It will need strong technical capabilities, a skilled workforce, a reliable supply chain, digital enablement, and the ability to move confidently from development through to commercial manufacturing.

This is particularly important in ASEAN, where the industry continues to grow, but not every market will develop at the same pace or in the same way. Customers need partners who understand not only the technology, but also the realities of executing successfully across a diverse regional landscape.

At Cytiva, we support customers throughout this journey—from process development and scale-up to facility design, workflow selection, single-use implementation, downstream processing, and commercial readiness. Increasingly, customers are looking not only for technology, but for practical experience, regional coordination, regulatory understanding, and support that helps minimize execution risk. Our role is to help customers build manufacturing models that are scalable, compliant, and sustainable, while staying close to the needs of patients and healthcare systems across ASEAN. That combination of technology, process knowledge, and partnership will be critical to the next phase of biomanufacturing growth in the region.

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