Outsourcing API development is one of the most important decisions a small biotech will make. With limited internal resources and compressed timelines, your choice of CDMO will directly affect whether your drug product reaches clinical trials on time and on budget.
To help biotech leaders make informed decisions, we spoke with Dr. Scott L. Dax, a veteran pharmaceutical consultant with decades of experience managing successful CDMO partnerships. Based on his insights, here are six key questions every biotech company should ask—and the hidden risks they help avoid.
Most biotechs wait until a Development Candidate is finalized before reaching out to a CDMO. But according to Dr. Dax, that approach often misses critical opportunities. Engaging a CDMO earlier—during late Lead Optimization can surface process risks, guide route design, and contribute to the creation of valuable process IP.
“The strike zone for a biotech is to really start talking to the CDMO before they have their Development Candidate,” he said. “The more that they can learn about your chemical series, the better they can serve the client.”
Rather than waiting for internal green lights, involve your CDMO early enough to shape decisions that will affect scalability, compliance, and long-term manufacturability. Waiting too long can mean missing out on valuable insights—and locking in suboptimal decisions that are difficult to reverse.
Not all CDMOs are equally equipped to handle every type of molecule. Your compound’s synthetic route (and types of reaction classes), safety considerations, and scale-up challenges require a partner with the right experience, not just the right equipment. Dr. Dax stresses that companies often undervalue technical fit in favor of speed or cost, and that’s a mistake.
“The real focus should be on the science,” he said. “Too often, people get caught up in the expense and timelines without understanding where the gaps exist.”
Overlooking technical alignment can lead to delays, inefficiencies, or even safety incidents that jeopardize your entire development plan. To avoid this, make sure you ask for:
The quality of your working relationship often determines the success of your CDMO partnership. For that reason, it’s essential to ensure you’ll have consistent access to the CDMO’s A-team—not just project managers or junior staff.
“Nothing takes the place of getting some face-to-face time,” Dr. Dax said. “Assign one person from the CDMO and one from the biotech client for specific action items and have them work together.”
Tech transfer is one of the most common points of failure in API outsourcing. Biotech companies often underestimate how much documentation and context is required for a CDMO to replicate their process.
“Biotech companies often need some coaching on what to expect and what to provide in order to make tech transfer efficient,” Dr. Dax explained, adding that many CDMOs may not clearly articulate what they need upfront.
To avoid issues, ask prospective partners to spell out their tech transfer requirements early. A strong transfer package should include not only detailed experimental procedures but also data, troubleshooting notes, and insight into what has or hasn’t worked in past iterations. Without that level of transparency, your CDMO may be forced to make assumptions that often lead to rework, delays, and increased costs.
While modern CDMOs generally have strong safeguards in place, biotech teams must ensure that intellectual property terms are clearly defined from the outset. That includes invention rights, data ownership, and co-development scenarios.
“Very importantly, biotech companies should make absolutely sure that the agreement or the contract explicitly transfers the rights of the invention to the biotech organization,” Dr. Dax said, emphasizing that legal language should be reviewed carefully.
Don’t assume standard boilerplate will cover all situations. Unclear or overly generic IP terms can lead to disputes that delay progress and erode trust between partners.
The best CDMO partnerships require flexibility from both sides. As your compound advances from Discovery to Development, changes to your synthetic route are often essential for successful scale-up. Your CDMO should be comfortable recommending these modifications, and you should be prepared to consider them seriously.
This flexibility can create tension for biotech teams who are naturally protective of their internal work.
“There's almost a reluctance to part with the work that was so elegantly done by the biotech chemists in favor of what a CDMO group recommends,” Dr. Dax said. “But that elegant chemistry may not be suitable for manufacturing scale.”
To avoid these issues, look for CDMOs that demonstrate a track record of growing their capabilities based on client needs. This indicates a partner who listens to feedback and invests in long-term relationships.
Dr. Dax points to GL CHEMTEC as an example of this approach:
“What I like about GL CHEMTEC is they continue to add expertise and develop capabilities,” he said. “That tells me that a company has been listening to their clients when they ask for something they don't have.”
GL CHEMTEC is passionate about your success and committed to solving your most complex chemistry challenges. We offer fast, flexible, cutting-edge solutions to take your medicinal chemistry and early-stage small-molecule routes to the next level. Our commitment to a collaborative partnership means we scale and adapt precisely to meet your evolving needs.
GL CHEMTEC provides:
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