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When Politics Scope Creep: Rethinking Biotech Manufacturing in a Shifting World
- Sarah Sink
- Jun 2
- 2 min read
Updated: Aug 3
“Scope creep” is a familiar term for anyone in the CDMO or biotech business. It’s usually the result of technical ambiguity or evolving program priorities needing a change of activities. But lately, the biggest scope creep isn’t coming from science, it’s coming from politics.
With newly proposed and enacted tariffs on products worldwide and the rising emphasis on domestic manufacturing, we’re watching a shift in how biotech companies, especially small to mid-sized innovators, approach manufacturing strategy. The conversation is no longer just about quality, cost, and timelines. Now it includes geopolitics, trade barriers, and global supply chain risk.
For CDMOs, the implications are substantial.
Clients Are Pivoting… But Can They?
There’s a growing wave of client interest in reshoring or “friendshoring” clinical and commercial manufacturing. For some, it’s about control and proximity. For others, it’s a hedge against increased costs and unpredictability caused by shifting trade policies.
But here’s the uncertainty: Are these tariff changes a short-term disruption? A 6–12 month policy cycle? Or a structural shift that’s here to stay?
No one knows for sure.
And that’s the real challenge: building or pivoting a manufacturing strategy on an unstable policy foundation can introduce as much risk as it aims to reduce.
US Capacity: Is There Enough?
Even with increased investment over the last few years, domestic manufacturing capacity remains tight, particularly for sterile fill-finish, biologics, and cell and gene therapies.
If global biotech programs were to rapidly pivot toward U.S.-based facilities, we’d likely face a capacity bottleneck. Available slots, technical onboarding, tech transfers, and regulatory inspections all take time. In many cases, timelines stretch well beyond what clinical programs can tolerate without causing disruption.
Add in the need for regulatory requalification, and the runway gets even longer.
Clinical Trials and Commercial Supply: The Domino Effect
Changing manufacturing sites mid-program is not trivial. It can delay clinical trials, create new regulatory risks, and, if widely replicated, disrupt commercial drug supply chains.
What starts as a tariff-related pricing concern could cascade into access issues for patients. Life-saving medications may face delays. Investigational drugs could miss trial milestones.
And patients, especially those relying on rare or niche therapies, could feel the impact first.
Advice for CDMO Business Development Professionals
As BD professionals, this is a time to think strategically and support clients beyond the scope of the original project.
Stay informed: Monitor international trade developments, not just for your own region but across key biotech manufacturing hubs.
Educate clients: Help them understand the real timelines, risks, and regulatory requirements involved in site transfers or shifts in strategy.
Promote flexibility: Offer solutions that accommodate dual-sourcing, phased transfers, or regional diversification.
Think globally, act locally: Whether you're based in the U.S., EU, or elsewhere, understanding global capacity constraints gives you a strategic edge.
Anchor on the patient: In all discussions, frame the impact in terms of the end goal, timely access to safe, effective medicines.
Final Thought: Don’t Let Scope Creep Become a Strategic Sinkhole
It’s wise to adapt to changing global conditions, but reaction without strategy can backfire. Tariffs may come and go. Facilities may open or close. What lasts is your ability to build trust by helping clients make sound, patient-centered decisions.
And that’s what separates a vendor from a true partner.
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