March 18, 2025

By: Gary Henderson

6 Common Pitfalls in CDMO Partnerships—and How to Avoid Them

Intro
From small biotech startups to global pharmaceutical giants, many companies rely on Contract Development and Manufacturing Organizations (CDMOs) to bring their products to market more efficiently. Outsourcing can accelerate timelines and reduce up-front investment in facilities, but it also brings risks if not managed properly. Below are six common pitfalls teams face when partnering with a CDMO—and strategies to ensure a smoother, more successful collaboration.

1. Overlooking Detailed Project Scope and Goals

Pitfall: In the rush to get started, sponsors often skip a thorough scope definition. They provide only high-level objectives, hoping the CDMO’s expertise will “fill in the gaps.”

Solution:

• Align Early on Project Details: Outline deliverables, critical milestones, and quality criteria in a written document.
• Define Success Metrics: Whether it’s yield targets for an upstream fermentation process or specific release criteria for finished drug product, discuss the metrics  with your CDMO to incorporate the necessary development required in the scope of work.
• Use a Phase-Gate Approach: Build in formal checkpoints (e.g., pre-clinical scale-up, pilot runs, GMP batch release) to review progress and adapt plans.

Why It Matters: Without clear scope and goals, small misunderstandings can balloon into missed timelines and budget overruns.

List Labs Inside Tip: Having a detailed plan makes it possible to compare CDMO partners on a level playing field. Don’t assume that the price you see encompasses all the activities that you expect it to. If a CDMO isn’t willing to go through this exercise with you to earn your business, what will it be like working with them once you have committed? 

2. Underestimating Technology Transfer Complexities

Pitfall: Some sponsors assume a direct “plug-and-play” transfer of their lab protocols to the CDMO’s facilities. In reality, technology transfer can be one of the most challenging parts of the partnership.

Solution:

• Conduct Feasibility Assessments: Before large-scale work begins, perform scaled-down runs or pilot runs.
• Process Transfer: Provide detailed SOPs, process parameters, and analytical methods. Record learnings in a tech transfer package or report.
• Collaborate Closely: Assign dedicated points of contact—both for the sponsor and the CDMO—to manage the data exchange.

Why It Matters: Properly executed tech transfer saves time and money by smoothing out issues before they become major roadblocks at scale.

List Labs Inside Tip: In the development stages, what makes a process work vs. not work can be unknown. There may be critical factors that you are not even aware are critical. Differences in equipment, technique, or a myriad of other factors, may influence how the process works in our hands versus yours. We can’t emphasise the importance of this step enough. 

3. Neglecting Regulatory and Compliance Requirements

Pitfall: Some sponsors forget that a CDMO must adhere not just to FDA cGMP or EMA GMP but potentially to global standards if the product will be marketed internationally. Missing a single compliance step can lead to costly delays.

Solution:

• Confirm Compliance: Ensure the CDMO has cGMP compliance according to the FDA, EMA, or PMDA and is able to host an audit to demonstrate compliance. 
• Check Regulatory Support: If you need help with an IND or MAA submission, working with a regulatory consultant with vested interest in your success is highly advised.
• Stay Updated: Regulatory guidelines evolve. Establish a process for ongoing compliance checks and updates.

Why It Matters: Ensuring compliance from the get-go is far more cost-effective than dealing with product recalls or remediation efforts later.

List Labs Inside Tip: Early phase cGMP drug manufacturing sites do not require FDA certification. If an early phase CDMO has been audited by the FDA, this could be due to a past adverse event, and a red flag.

4. Assuming Infinite Capacity and Rapid Timelines

Pitfall: It’s easy to assume a CDMO always has available capacity and can meet any timeline you propose. In reality, many leading CDMOs juggle multiple projects, causing scheduling conflicts.

Solution:

• Map Out Resource Availability: During initial discussions, request a capacity forecast and typical lead times.
• Build in Buffer: If you have a tight clinical milestone (e.g., needing trial materials by Q4), pad your timeline for unexpected delays.
• Raw Material Availability: Knowing what raw materials and disposables are required for your project and researching the lead time to acquire them, can prevent unexpected delays. 

Why It Matters: Realistic timelines and capacity checks help prevent last-minute surprises or bottlenecks that can derail entire development programs.

List Labs Inside Tip: Start conversations with CDMO’s sooner rather than later. You may think you are not far enough along, but those early conversations can lead to time savings down the road. For example, if there are activities in your process that are not scalable, or compatible with GMP, better to make those adjustments early. 

5. Underestimating the Financial Implications of Changes

Pitfall: Project plans rarely stay static—especially in pharmaceutical drug product development . But each change (e.g., altering formulation, adjusting batch size) can trigger unplanned costs.

Solution:

• Establish a Change Control Process: Any modification to the scope, timeline, or technical details should be evaluated for cost and schedule impact.
• Keep a Contingency Budget: Set aside a portion (e.g., 10–15%) of the total budget for unexpected scope expansion.

Why It Matters: Clear financial oversight prevents tension between sponsor and CDMO—and helps keep your project on track fiscally.

List Labs Inside Tip: By choosing a CDMO with decades of experience, you will likely be the recipient of some sage advice that will inevitably help reduce or eliminate the need for costly changes later. We recommend heeding that advice!

6. Relying on One-Way or Sporadic Communication

Pitfall: In a purely transactional relationship, the CDMO updates the sponsor only when they must (e.g., monthly reports or critical deviations). This can leave sponsors in the dark about emerging issues.

Solution:

• Regular Check-Ins: Schedule weekly or biweekly calls, plus a monthly governance meeting.
• Set Communication Protocols: Decide how quickly urgent updates (like QC failures) will be escalated and via which channels (email, phone call, project portal).
• Collaborative Tools: Use shared project management software or cloud-based data rooms to keep both teams aligned in real time.

Why It Matters: Frequent, transparent communication fosters trust and allows both parties to address potential problems before they escalate.

List Labs Inside Tip: Having a dedicated project manager as your main point of contact is vital to ensuring effective, efficient communication. 

 

Final Thoughts

CDMO partnerships can be a game-changer for companies looking to bring novel therapeutics—whether biologics, protein, or Live Biotherapeutic Products —to market faster and more efficiently. But success hinges on clear communication, robust planning, and mutual understanding of expectations.

By avoiding these six pitfalls—from scope definition to communication—you’ll be well on your way to a productive, trust-based relationship that benefits both parties. After all, the right CDMO isn’t just a vendor; it’s a partner in the journey to your success to deliver safe, effective treatments to patients worldwide.

Interested in More?

If you’d like additional insights into optimizing your CDMO collaboration, stay tuned for our next blog post on key metrics to track during tech transfer and how to manage regulatory audits effectively. Feel free to leave a comment or question below, and our experts will get back to you.

Disclaimer: The contents of this blog post are for informational purposes only and do not constitute legal or regulatory advice.