Q&A: Cytiva’s Pierre-Alain Ruffieux on Scaling Cell and Gene Therapy Manufacturing for Global Access

Ahead of the 2026 BIO International Convention (BIO 2026), taking place June 22–25 in San Diego, Calif., BioPharm International® spoke with Pierre-Alain Ruffieux, PhD, group executive, Bioprocess, Cytiva, about current trends in biomanufacturing. In this Q&A, Dr Ruffieux addresses several challenges and opportunities facing the advanced biomanufacturing sector, including how the industry can scale cell and gene therapy production to improve global patient access, the role of regional manufacturing networks in strengthening supply chain resilience, strategies for addressing the ongoing shortage of specialized biomanufacturing talent, and how emerging regulatory pathways, such as FDA’s Advanced Manufacturing Technologies (AMT) designation program, may support the adoption of more sustainable and efficient manufacturing technologies. Dr Ruffieux also discusses the technologies expected to define the next generation of flexible, resilient biomanufacturing and shares his perspective on the key priorities for stakeholders across the advanced biomanufacturing landscape.

BioPharm: How can the biomanufacturing sector scale cell and gene therapy production to improve global patient access?

Dr Ruffieux (Cytiva): Cell and gene therapies are often life-changing for patients; however, high costs and technological constraints remain barriers to access. Scaling these therapies globally will require manufacturing that is more consistent, reproducible, and cost-effective. Current processes are complex, often patient-specific, and difficult to reproduce consistently at scale.

Progress will depend on increasing standardization and automation to reduce variability and improve process control. Platform-based and modular manufacturing approaches are beginning to address these issues by enabling more predictable scale-up and scale-out.

Advancing these therapies also requires tighter integration across discovery, development, and manufacturing, supported by sustained collaboration across the biopharma ecosystem.

What are the key benefits of reshoring manufacturing for supply chain security and national resilience?

Regionalization is increasingly viewed as a risk mitigation strategy rather than purely an economic decision. The advantages of a more local supply chain became clear during the COVID-19 pandemic, when disruptions exposed the vulnerability of complex international networks.¹ Regional manufacturing networks can improve supply continuity, reduce lead times, and better align production with local regulatory and patient requirements.

At the same time, advanced biomanufacturing relies on globally distributed supply chains for materials and expertise. As a result, resilience strategies need to balance regional capacity with continued cross-border coordination.

How can the biopharma industry address the global talent shortage to build a future-ready biomanufacturing workforce?

Talent constraints remain a key limiting factor for advanced manufacturing. Data from Cytiva’s 2025 Global Biopharma Index found that approximately 38% of executives report severe shortages in specialized skills, particularly in emerging and more complex modalities such as cell and gene therapies, mRNA [messenger RNA], and antibody-drug conjugates (ADCs).²

Addressing this gap will require a combination of expanded training, workforce development, and closer alignment between academic programs and industry needs. Building capabilities in good manufacturing practice (GMP) operations, digital technologies, and advanced bioprocessing will be particularly important.

There is also a broader need for the industry to strengthen its appeal to younger talent. While attention is currently focused on fields such as artificial intelligence (AI), biopharma continues to offer some of the most complex scientific challenges, alongside the opportunity to improve patients’ lives.

In parallel, broader talent strategies, including cross-border recruitment, will be required to support workforce scalability, together with government policy that supports overseas recruitment.

In what ways do new regulatory pathways help accelerate the adoption of sustainable manufacturing?

Regulatory frameworks are a central factor in enabling both innovation and sustainability. Existing pathways, largely designed for traditional biologics, are not always well suited to platform-based or patient-specific therapies. Regulatory pathways that are predictable, science-based, and adaptive will be critical to accelerating innovation while supporting long-term sustainability goals.

There is growing interest in platform-based regulatory approaches, which evaluate standardized components rather than requiring full reassessment of each individual therapy. This has the potential to reduce development timelines and increase consistency across manufacturing processes. Pathways such as FDA’s [AMT] designation program³ also reflect a shift toward enabling more efficient adoption of innovative manufacturing approaches. More broadly, regulatory clarity and predictability are key to enabling investment in new manufacturing technologies, including those aimed at improving resource efficiency and reducing environmental impact.

What technologies will define the next generation of flexible, resilient biomanufacturing at scale?

The next generation of biomanufacturing will be defined by how effectively the industry integrates scientific advances with engineering, digital intelligence—including AI—and operational execution at scale. As processes become more complex and product pipelines more diverse, the priority will be to build manufacturing systems that are more connected, adaptive, and capable of delivering consistent quality with greater speed and predictability.

Process intensification approaches are enabling higher yields and more efficient use of infrastructure. In parallel, digital technologies, particularly process analytical technologies and real-time monitoring, are improving process visibility and enabling predictive control. Modular manufacturing platforms are also gaining traction, allowing facilities to adapt more readily to different products and production scales. The impact of these technologies depends on their integration across the entire value chain, from discovery through commercial manufacturing, as well as their ability to support consistent quality and regulatory compliance.

Given current trends and industry pressures, what is the key take-home message for stakeholders in advanced biomanufacturing?

Stakeholders require the highest-quality products. While that should be a given, the industry is not yet delivering it consistently, which is why there is such a strong focus on reducing variability.

The other challenge facing advanced biomanufacturing today is not a lack of innovation but the ability to translate that innovation into scalable, accessible therapies. Scientific discovery is accelerating, but manufacturing systems are under increasing pressure to keep pace.

Addressing these challenges requires coordinated improvements across key areas, including manufacturing agility, supply chain resilience, access to skilled talent, and regulatory alignment. If the underlying systems that enable therapies to be developed, produced, and delivered at scale can be strengthened, the distance between discovery and patient impact can be significantly shortened.

Cytiva will be giving a virtual presentation at its booth, 2027, at BIO 2026, titled, “Changing Innovation Paradigms—A Navigator’s Guide,” on June 23.

References

1. World Health Organization. WHO Director-General's opening remarks at the media briefing on COVID-19 - 11 March 2020. March 11, 2020. Accessed June 15, 2026. https://www.who.int/news-room/speeches/item/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020
2. Cytiva. Industry faces talent crunch and regulatory strain, according to third Global Biopharma Index from Cytiva. Published October 6, 2025. Accessed June 15, 2026. https://www.cytivalifesciences.com/en/us/news-center/industry-faces-talent-crunch-and-regulatory-strain-10001
3. FDA. Guidance for Industry, Advanced Manufacturing Technologies Designation Program (CDER, CBER, December 2024). Accessed June 15, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/advanced-manufacturing-technologies-designation-program