top of page
Search

Is This CDMO Scalable with Your Program? Questions to Ask

  • Writer: Sarah Sink
    Sarah Sink
  • Aug 14, 2025
  • 3 min read

When you’re evaluating a CDMO, it’s easy to focus on the now, the immediate milestone, the current batch, the quote sitting in your inbox.


But what happens three steps down the road?


That’s where things can get tricky.

Because the CDMO that’s perfect for your tox batch or early Phase 1 work may not be the partner who can scale with you into pivotal trials or commercial readiness. And you don't want to find that out mid-program, when tech transfer déjà vu and manufacturing delays become the cost of not planning ahead.



It’s Not Just About Capabilities; It’s About Growth Compatibility


I’m not saying you need to pick your forever CDMO on day one. That’s rarely realistic, especially for lean teams and virtual biotechs managing burn rates.


But I am saying you need to think beyond the quote.


Ask yourself:


  • If this program goes well, is this CDMO built to grow with us?


  • Will their systems, capacity, and quality oversight still make sense 12–18 months from now?


  • Can we expand scope without starting from scratch?


The earlier you think about scalability, the more options and leverage you’ll have when it matters most.



6 Questions to Assess CDMO Scalability


Here are a few questions I recommend asking during your CDMO evaluation process. None of them are particularly technical, but each one can reveal a lot about long-term fit.



1. How do they handle internal prioritization?


If you’re a small fish in a large pond, will you stay visible when bigger clients need time on the same equipment or with the same team? Ask how they manage program conflicts and internal resourcing.



2. Can they support future phases, or would that require tech transfer out?


Not every CDMO needs to take you all the way to commercial, but it's helpful to know early if they see their role ending after Phase 1. Will you have to move DS, DP, or testing later? And what would that handoff look like?



3. What does expansion look like inside their facility?


Can they increase batch size, add SKUs, or support secondary packaging in the same site or network? Or does scale mean starting from scratch with a new partner?



4. Do they have an enterprise-wide quality system or is it site by site?


If you expand to another site in their network, how consistent will the systems, processes, and personnel be? Disjointed quality infrastructure can introduce unexpected delays during scale-up.



5. How flexible are their systems and tech platforms?


Rigid tech transfer templates, fixed raw material suppliers, or narrow equipment specs might be fine early on, but can become blockers if you need to pivot formulations or scale quickly.



6. Do they bring up scalability before you do?


This might be the biggest one. A true partner will proactively ask about your long-term plans and propose scalable solutions, not just quote what’s in front of them.



Common Mistake: Thinking You’ll "Just Figure It Out Later"


I see this a lot with early-phase programs: “Let’s just get through the tox batch and we’ll worry about the rest later.”


But guess what happens?


  • Batches have to be repeated due to method validation gaps


  • Timelines reset because the new CDMO won’t accept the prior data package


  • Your internal team ends up managing two tech transfers instead of one


None of that is efficient or cheap. Especially when you’re under pressure from investors or clinical milestones.



Want a Smarter Way to Vet Long-Term Fit?


If you want to evaluate scalability before locking in a partner, I have tools built specifically for biotech teams navigating these decisions:



A Scalable CDMO Isn’t Just About Size; It’s About Fit Over Time


You don’t need a global, multi-site CDMO to have a scalable relationship. You just need a partner who understands your program’s path and is set up to grow with you.


So, ask the questions now.


Because when it comes to manufacturing partnerships, short-term thinking can have long-term costs.



For more insights and personalized support in navigating the biotech-CDMO landscape, visit my website: www.yourpharmagirl.com and follow Your Pharma Girl on LinkedIn. Whether you need strategic guidance, tailored BD solutions, or expert advice on building lasting partnerships, I'm here to help you and your team succeed at every stage of development.

 
 
 

Comments

bottom of page