A Flexible Manufacturing and Workforce Modernization Q&A With Sebastián Arana

Speaking with BioPharm International® at the 2026 BIO International Convention (BIO 2026), Sebastián Arana, global head of process solutions at MilliporeSigma, the life science business of Merck KGaA, Darmstadt, Germany, discussed the operational and strategic priorities reshaping biomanufacturing today, from platform flexibility and workforce modernization to the unique scaling challenges posed by cell and gene therapies (CGTs).

BioPharm: How can the biomanufacturing sector lower manufacturing costs to make advanced therapies more accessible for patients?

Arana (MilliporeSigma): It is really exciting times in biotech as the industry continues to advance toward more complex and targeted therapies. The challenge is making those therapies more efficiently at scale so that more patients can have access and benefit from new therapies. Clinical timelines are getting shorter and shorter, so customers will need to have reliable products supporting these therapies.

To lower cost, we need to simplify processes, improve yields, and ultimately reduce production times and cost of production. The number one thing we see is flexibility in platforms that will help manufacturers support different modalities and different volume needs‚ because different molecules will have different expectations and different needs. Things like automation, digital tools, and real-time monitoring will be critical as we move forward. At MilliporeSigma, we are launching and have launched new technologies and products to help move toward that vision, but it is definitely a critical goal for the industry as a whole.

What are the main hurdles in building a facility to handle multiple types of biotherapeutics, especially in light of increasingly complex modalities?

The challenge is not just fitting new equipment into an old facility or building. It is about being able to integrate fundamentally different manufacturing philosophies into a new operating model. Basic things like facility flow are typically one of the first obstacles that companies need to manage, and segregation and contamination control also introduce complexity‚ especially for legacy sites that were originally built for something different. Data systems also become more fragmented, and data flow becomes more critical when new modalities are layered into an existing manufacturing process.¹

A final thought here: You can modernize equipment, invest in capital expenditure, and build a new manufacturing line, but you need to also consider retraining your teams and account for all the human factors that are critical, because a new modality often requires a completely new way of working for the site. Those elements all need to be considered together.

How can companies remain competitive as biotherapeutic manufacturing continues to evolve so rapidly?

One of the biggest planning challenges today is that pipeline composition will change dramatically and become even more diverse over the next several years, and that itself will create significant impact for the industry. I feel the winners over the next decade or so will be companies that build adaptability into their manufacturing ecosystem‚ not just manufacturing capacity. Many years ago, capacity was everything, but today, capacity is table stakes; everyone expects that from you. What has become more critical is flexible manufacturing: modular, digital-enabled, and fundamentally platform-based.

No company can independently build deep expertise across all new modalities, so the ones that try are probably spreading themselves too thin. Becoming specialized and focused in a few modalities that you want to concentrate on is becoming critical. And as I was mentioning, workforce training and workforce modernization has become a more strategic imperative than before. That is not just an operational consideration—it is a competitive differentiator.¹

Which innovations do you think will have the biggest impact on being able to scale CGTs?

The CGT space is evolving, and we are probably still in early phases. Where CGT is today is roughly where monoclonal antibody manufacturing was 25 to 30 years ago, so there is a great deal of process optimization, automation, and rethinking of manual steps that still needs to happen. The biggest opportunity is moving from highly manual, customized processes to something scalable and reproducible from a manufacturing perspective. Advanced analytics and real-time monitoring will play a role here, but there is still significant innovation that needs to come.

What is the most critical factor for success when moving these complex therapies into commercial production?

All our customers and the industry continue to learn here, and I think that is what makes this such a dynamic space. What we have seen is that process characterization gaps are one of the most persistent and clear challenges that manufacturers continue to navigate as they scale up their processes.²

Technology transfer is also increasingly sensitive in biological systems. It is very much a need, and it is a particularly delicate operation when some of these medicines are manufactured or produced at one site and need to be reliably transferred to different sites. Scaling is now deeply interconnected with supply chain coordination. One of the clearest lessons from the COVID-19 pandemic was that supply chain is even more critical than previously appreciated, and there are multiple considerations CGT manufacturers need to account for here.³

Finally, I would say analytical readiness consistently lags behind manufacturing scale ambitions. That is something companies also need to proactively address as they expand their science in this space. Process characterization, technology transfer, supply chain coordination, and analytical readiness—those are 4 elements that any organization needs to consider carefully as they scale up in this technology area.^2,3

What is the key take-home message from BIO 2026 for stakeholders in the advanced modality space?

I would say it is more confirmation than revelation. The science continues to move extremely quickly, and it is even hard for manufacturing companies like us to keep up with all the changes and all the different technologies emerging.

Collaboration continues to be something the industry needs‚ between science, manufacturing, and large pharma and biotech companies, as well as suppliers like us and CDMOs, which are playing an increasingly important role. Flexible manufacturing is another clear theme from BIO, along with digital tools and strong partnerships in that space.

Above all, success is not only developing a new therapy but making it consistently manufacturable and scalable. At BIO, I saw a lot of great technology, a lot of great startups, and a lot of great ideas‚ but if you cannot manufacture it, produce it, and scale it up, at the end, it is just a good idea. Our role at MilliporeSigma is to close that gap, continue to partner with biotech companies, and help them transfer science into something they can produce‚ and, ultimately, advance therapies to more patients.

References

1. Barton C. Frontrunners in automated cell and gene therapy manufacturing. Pharmaceutical Technology Europe. 2024;36(7):14-16. Accessed July 17, 2026. https://www.pharmtech.com/view/frontrunners-in-automated-cell-and-gene-therapy-manufacturing
2. Hewitt M, Bellot L, Andersen C. Best practice tech transfer methods for CGTs. BioPharm International. 2023;36(11):30-33. Accessed July 17, 2026. https://www.biopharminternational.com/view/best-practice-tech-transfer-methods-for-cgts
3. Samsung Biologics. Agile and reliable technology transfer for complex modalities. Updated September 3, 2025. Accessed July 17, 2026. https://samsungbiologics.com/media/bio-story/agile-and-reliable-technology-transfer-for-complex-modalities