Mike Schaefers, Chief Commercial Officer at Simtra BioPharma, outlined what it takes to build durable CDMO partnerships in injectable manufacturing, why regional supply chains have become a permanent feature, and how early-phase collaboration directly shortens time to market.
The Case for Regional Manufacturing
Simtra BioPharma became an independent, privately owned company two years ago, but its manufacturing heritage in injectable drug products goes back decades. That history, Schaefers argued, is inseparable from its current strategy of building parallel capabilities in North America and Europe.
The shift toward regional manufacturing, he said, did not start with recent geopolitical developments. “I think it has intensified over the last couple of years,” Schaefers noted, tracing the trend to COVID-era supply chain failures that exposed how fragile globally integrated manufacturing networks could be. For clients, the calculus now involves two distinct priorities: de-risking supply and managing cost. Where domestic production can address both, it will. Simtra has positioned itself to offer development services, clinical batch manufacturing, and commercial manufacturing from both regions, giving clients a choice based on their specific exposure.
Asked whether this was a temporary response to current pressures or a structural shift, Schaefers was direct. “I think it’s there to stay.”
The Limits of the One-Stop Shop
Schaefers pushed back on the growing appeal of the “integrated CDMO” model, though carefully. The injectable value chain, he argued, runs from active pharmaceutical ingredient (API) manufacturing through drug product, secondary packaging, device assembly, and clinical trial management. No single organization currently executes that entire chain well.
“There is no company really being able to address that in a good way,” he said. Strategic partnerships between best-in-class specialists are, in his view, a more credible solution than consolidation within a single entity. But such partnerships require substantial preparation before they can be credibly offered to a client. Both parties must define project management protocols, milestone structures, handover steps, and key contacts. “Only if that’s properly managed and prepared, you’re really ready to offer a solution to a client.”
Simtra’s own investment thesis reflects this. Recognizing growing demand for cytotoxic and high-potency injectables, the company moved to replicate its API and high-potency manufacturing capabilities from Germany into North America to serve commercial-stage clients in that market.
Client Collaboration
For injectable manufacturing, quality is non-negotiable, Schaefers said, but it is the baseline, not the differentiator. What separates successful partnerships is the timing and depth of client involvement.
Ideally, Schaefers argued, a CDMO and sponsor should begin working together at the formulation development stage. Early involvement allows the CDMO to recommend container closure systems suited to both the drug and the manufacturing process, to develop lyophilization cycles, and to ensure that what is produced during clinical phases can scale into commercial manufacturing without rework. “If you have a seamless development and upscaling process, you are getting to the market very quick.”
Flexibility across sites, sufficient reserved capacity, and clear communication round out the requirements. On transparency, Schaefers gave a practical example: if a client’s API supply is delayed, early notification allows the CDMO to reschedule, preserving the production slot and limiting the downstream impact. The alternative, discovering the delay too late, results in a lost slot and a longer overall delay for the client.
Capacity as the Immediate Constraint
The hardest part of the job right now, Schaefers said, is matching available capacity to accelerating demand. Clients historically sourced from Europe are requesting North American capacity, and vice versa, driven by the same risk mitigation logic. “Balancing that with the available capacity is a challenge.” Simtra’s proactive investment in capacity ahead of this shift has put it in a stronger position than many peers.
On the role of GLP-1s in the sterile manufacturing capacity crunch, Schaefers offered a measured view. GLP-1 demand has contributed, but it is not the full story. Biologics pipelines continue to grow, and new modalities such as antibody-drug conjugates (ADCs) and bioconjugates require specialized capabilities and infrastructure that cannot be stood up quickly. “Just having it on the paper doesn’t mean you can do it.”
Takeaways
- Engage CDMOs at the formulation development stage, not after regulatory filing, to enable smooth scale-up and reduce time to market.
- Treat regional supply redundancy as a structural requirement, not a contingency; clients in both North America and Europe now actively seek it.
- Evaluate claims of “end-to-end” CDMO capability critically: the injectable value chain from API to device assembly is too complex for any single organization to execute well across the board.
- Build API supply transparency into partnership agreements from the outset; early notification of delays preserves production slots and limits schedule impact.
- Invest in specialized capabilities for ADCs and bioconjugates ahead of demand; stated capability without operational track record carries real execution risk.
- Distinguish transactional relationships from strategic ones; products in growth or launch phases require active engagement from both sides to deliver on time-to-market goals.
