We recently explored the importance of timing and trust when choosing a CDMO partner and the key questions you should be asking potential collaborators. But finding the right CDMO partner is only half the battle.
Many biotech companies focus intensively on CDMO selection while overlooking the internal preparation that determines partnership success. The result is often miscommunication, delays, and partnerships that fail to deliver their full potential.
In this second part of our series on maximizing success with CDMO partners, we continue our conversation with Dr. Scott L. Dax, a pharmaceutical consultant with over 25 years of experience at companies ranging from Johnson & Johnson to early-stage biotechs.
Dr. Dax's message is clear: successful outsourcing starts with internal preparation. Here's how to get your organization ready for a strategic CDMO partnership.
Before you can effectively evaluate CDMO partners, you need a brutally honest assessment of your chemistry and what capabilities your team lacks.
"Start by taking a close look at your medicinal chemistry program and specifically the synthesis of your API (Active Pharmaceutical Ingredient), what makes it challenging and unique. Then see if there are skill sets at the CDMO that will confidentially allow for GMP synthesis, manufacturing, analytical, and quality components,” Dr. Dax said.
Consider factors like specialized reaction classes, equipment requirements for extreme conditions, safety hazards that require specific handling expertise, and analytical methods that demand particular instrumentation. Next, conduct an honest audit of your internal capabilities, looking at elements like:
“Biotech companies typically have missing skill sets; they have gaps. They need to talk to the CDMO to understand where the gaps are and confirm what the biotech team really needs,” Dr. Dax said, explaining that this dialogue helps validate your internal assessment and ensures nothing critical gets overlooked.
Finally, prepare comprehensive technical documentation before starting serious CDMO discussions. This includes experimental protocols, analytical data, and process optimization. “Simple things like providing detailed experimental procedures are often lacking or missing entirely. You don't want your CDMO partner to have to do a lot of guesswork and go back and start all over again,” Dr. Dax said.
Next, focus on establishing clear roles and decision-making authority from the start. Ambiguous responsibilities can create delays and frustration for both parties.
“There should be very clear shared responsibilities, giving authority to members from both the biotech as well as the CDMO,” Dr. Dax said, explaining that you should define who has authority to approve process modifications, how changes will be communicated and documented, escalation procedures for technical issues, and regular review schedules.
Finally, prepare for the reality that your lab-scale chemistry may need significant modifications for manufacturing scale. This is often one of the most difficult aspects of API outsourcing for biotech teams.
"Sometimes there's almost a reluctance to let go of the work that's been done by the biotech chemists in favor of what a CDMO group recommends," Dr. Dax said. “Even the most elegant chemistry may not always be suitable for GMP synthesis or manufacturing scale.”
Successful partnerships require the recognition and willingness that manufacturing requirements may drive changes to the drug discovery synthetic routes. These changes are built upon your trust in the CDMO's scale-up expertise.
“Companies should certainly have their new chemical entities covered in patent applications that have already been filed,” Dr. Dax said, emphasizing that this includes:
Patent landscape analysis for freedom to operate
Next, don't assume your standard contract language adequately covers intellectual property rights.
“Very importantly, companies should make absolutely sure that the agreement explicitly transfers the rights of any invention—the assignment, as we call it—to your organization,” Dr. Dax said, explaining that contracts should also identify CDMO scientists as potential inventors and define data ownership and usage rights.
Successful CDMO partnerships require thinking long-term. Many biotechs focus narrowly on their next milestone—IND filing, first-in-human trial, or initial scale-up—without considering how their needs will evolve through later clinical phases and commercialization. This short-term mindset often forces costly and disruptive transitions between providers at critical points.
“To really set the foundation for growth, things like robust supply chains and proper documentation can't just be boxes to check at commercialization; they need to be built into the program from day one,” Dr. Dax explained. “The best CDMOs understand this, but many biotechs underestimate how much it matters until they're scrambling to meet requirements.”
To avoid these pitfalls, biotech leaders should seek out CDMOs that go beyond executing today’s tasks and invest in capabilities that anticipate tomorrow’s challenges. That adaptability is what separates transactional vendors from true partners.
“As an example, I’ve known GL CHEMTEC for over two decades, and they have continued to add expertise and expand capabilities over the years,” Dr. Dax said. “That tells me they’re not just focused on delivering single projects; they’re positioning themselves to grow with their partners.”
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: