The biologics external manufacturing panel at CDMO Live 2025, sponsored by BSP Pharmaceuticals, brought together industry leaders to tackle the key challenges in scaling biological manufacturing amid geopolitical tensions, capacity constraints and evolving partnership models.
The panel featured Olaf Birkenmeier, Head of External Manufacturing at Polpharma Biologics; Julien Laizé, Director of External Manufacturing CTM at Valneva; Catherine Seigneur, Senior Director of External Manufacturing Business Lead at UCB; and Giorgio Salciarini, Head of Sales – Technical Business Development at BSP Pharmaceuticals.
The Challenge of Conflicting Priorities
The biosimilar sector faces particularly acute challenges in external manufacturing, according to Olaf Birkenmeier. “You want to be very flexible in the beginning, you need to have someone good in terms of quality that gets things right to meet target dates. But at the same time, you need someone who is, in the end, rather cheap because there will be significant price erosion,” he explained.
This balancing act becomes even more complex when dealing with uncertain volumes. Birkenmeier noted that “depending on your market entry, depending on the competition, and depending what the originator throws into your face to defend this, your volumes might be completely off from whatever you expect in the beginning.”
The Capacity Crunch
Catherine Seigneur from UCB highlighted capacity as her primary challenge: “How do I cope with growth? How do I cope with the fact that we do even better than we thought in a very constrained market?”
The challenge extends beyond current products to future pipeline uncertainty. “How do I cope with the uncertainty of what is coming next, in terms of type of pipeline, the size of that… I need to plan, because we are in this constrained market, making commitments and not spreading my bet too much in making those commitments,” Seigneur added.
Moving Beyond the Biosecure Act and Tariffs
Julien Laizé from Valneva revealed how geopolitical tensions, particularly the Biosecure Act implications, are already affecting decision-making. “When we want to develop a new drug or tech transfer, if we see a CDMO is Chinese or partially owned by a Chinese entity, very likely we’ll discard it,” he stated.
The concerns centre on two key areas: intellectual property security and capacity access. “If one day I produce for US in China, for US territory, and one day for any reason, China decides to invade Taiwan and blocks the vaccines that need to be sold in US, that’s a major problem for US security,” Laizé explained.
Catherine Seigneur pushed back against the notion that regionalisation is purely tariff-driven. “It’s a trend that has been there for a long, long time. It’s something we speak about for several years… A lot of the moves we saw about the investments, you cannot announce an investment of that size if you didn’t prepare it for quite a long time.”
However, Birkenmeier highlighted the challenges for smaller molecules and orphan drugs: “If you have some presentation of a vial where you have 5,000 units per year, and then if you think, okay, how do we split that into different manufacturing sites… it’s not really going to work for some of these things, or the prices will increase to some unacceptable level.”
Strategic Partnerships Over Tactical Relationships
The panel agreed on the need to move from transactional to strategic relationships. Giorgio Salciarini observed that “instead of targeting one project at a time with a variety of suppliers… Big Pharma, if they have the possibility, they have somehow internalised and also rationalised their relationship with the CDMOs, reduced the number of partners.”
Catherine Seigneur’s approach at UCB involves “trying to consolidate volumes from a platform point of view, not necessarily from a product point of view.” This strategy helps manage small volumes while maintaining efficiency.
Flexibility as the New Currency
Flexibility emerged as the paramount requirement, but with nuanced meanings. Laizé emphasised that beyond manufacturing slot flexibility, “we are living in a climate of uncertainty, with the geopolitical aspect, with the business aspect… flexibility is one of the major challenges that we ask from our CDMO.”
The panel described innovative approaches to achieving flexibility. Seigneur mentioned conducting “workshops with our CMOs to see how we can unlock capacity in different ways, interchanging products… if they add one shift on another line, can we gain capacity on our line?”
Laizé noted that “50% of your success rate with the CDMO is depending on the relationship… during the site visit, you can really see how it works at the CDMO site. You can perceive, you can feel the ambience.”
Key Takeaways
- Strategic partnerships trump cost savings: Companies are consolidating their CDMO relationships, prioritising quality and flexibility over lowest cost.
- Regionalisation is inevitable: The trend predates current geopolitical tensions and requires careful planning, particularly for smaller-volume products.
- Flexibility is paramount: From manufacturing slots to strategic pivots, agility has become the most valuable currency in external manufacturing relationships.
- Contracts must enable partnership: Long-term agreements with built-in flexibility mechanisms and interchangeability provisions are becoming standard.
- Relationships matter: Beyond technical capabilities and cost structures, the quality of human relationships determines partnership success.
As the biologics landscape continues to evolve amid geopolitical uncertainty and capacity constraints, successful external manufacturing strategies will increasingly depend on building deep, flexible partnerships rather than optimising for short-term cost savings.
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