CDMO Capacity Crunch: Are Biotechs Wasting Time On The Wrong CDMO?

By Tamika Drummond, Ph.D., CEO and founder, 3Kinnect Solutions Inc.

Early in my CMC journey, I came across the Development of Therapeutic Monoclonal Antibody Products guide published by BioProcess Technology Consultants.¹ One recommendation stopped me in my tracks: selecting and onboarding a CDMO can take up to nine months for early-stage programs and 12 months or more for Phase 3 and commercial programs, and that is before a single batch is manufactured.

In my experience, 12 months is closer to the baseline regardless of development phase, particularly for complex modalities like antibody-drug conjugates (ADCs) or combination products that require devices such as autoinjectors. These programs face not only longer onboarding timelines but also a shrinking pool of truly qualified CDMOs. To avoid getting caught in the CDMO capacity crunch, sponsors must engage potential CDMOs early, well before the first batch is needed. Many CDMOs book manufacturing slots months or even a year in advance.² Waiting until a few weeks before your batch is required puts you at serious risk of selecting whoever has availability, rather than the CDMO best suited to your program.

Beyond timing, a growing number of biotechs are running into a harder problem. For complex modalities like ADCs, demand is outpacing supply and experienced manufacturing slots are increasingly scarce. But availability is only part of the issue. Too many companies are burning time, money, and momentum pursuing CDMOs that were never the right fit for their program in the first place.

The Hidden Complexity Behind The Crunch

When people discuss CDMO capacity, the conversation gravitates toward visible metrics such as number of bioreactors, fill/finish lines, and facility size. For complex modalities, those numbers tell only part of the story. Success depends on less visible factors: expertise, flexibility, and responsiveness.

Consider ADC manufacturing. An ADC is not a single product; it is the integration of two distinct manufacturing disciplines. The payload, typically a small molecule and often highly potent, requires specialized containment infrastructure and expertise in handling hazardous compounds. The antibody intermediate demands a separate set of biologics manufacturing capabilities. Conjugating the two into a final drug substance requires proven conjugation processes and rigorous analytical methods for drug-to-antibody ratio (DAR) determination and release testing.³ Even though there are over 210 ADCs currently in clinical development,⁴ very few CDMOs offer all of these capabilities in-house. Fewer still have the available capacity and depth of expertise to take on new programs; as many as five separate CDMOs may be engaged to complete GMP manufacturing of a single ADC.⁴

Combination products present a similar and often underestimated challenge. Autoinjectors, prefilled syringes, and other drug-device combinations introduce entirely new manufacturing dimensions: container closure integrity testing, human factors engineering, and final device assembly.⁵ While many CDMOs offer sterile fill/finish, far fewer provide integrated support for the device component.⁶ The result is often a fragmented multivendor approach that multiplies coordination risk and stretches internal project management resources thin.

Are You Prioritized Or Just Parked?

When faced with limited capacity in specialized areas, biotechs often default to one of two flawed instincts: pursue the biggest name in the space or go with the lowest bidder.

The appeal of a large CDMO is understandable. Robust infrastructure, global regulatory experience, and an established track record are genuinely valuable. But at a large CDMO, an early-stage program competes for attention alongside commercial-scale projects. Access to senior technical personnel can be limited. Timelines that appeared reasonable during business development begin to slip once the program is onboarded.

Choosing a CDMO on cost alone introduces a different set of risks. What appears inexpensive at signing can become costly in practice through scope creep, change orders, and the compounding expense of delays.

A midsize or specialist CDMO often offers something that neither large nor low-cost CDMOs consistently deliver:

• Shorter onboarding timelines and faster project initiation
• Direct access to senior technical leads rather than rotating project managers
• Greater agility and responsiveness when issues arise
• Stronger alignment with the pace and priorities of an emerging biotech

This is not an argument against large CDMOs. They play an essential role as programs advance toward commercial scale. The point is fit matters more than size or price. Before signing any master service agreement (MSA), biotechs need to ask harder questions:

• Where will my program fall in your prioritization matrix?
• Do you have dedicated teams for ADCs, highly potent active pharmaceutical ingredient (HPAPI) handling, or drug-device integration?
• How do you manage emerging clients alongside your commercial portfolio?

The Opportunity Cost Of A Mismatch

A misaligned CDMO relationship costs more than time. Missed clinical milestones translate directly into lost investor confidence, weakened deal positions, and in some cases, programs that never regain momentum.

For smaller biotechs, each month of delay carries outsized consequences. Critical inflection points, including IND application submissions, first-patient-in dates, and licensing discussions, are often tightly sequenced. Slipping one can cascade through the rest.

Programs spanning multiple vendors across drug substance, drug product, and device manufacturing are especially vulnerable. Unclear communication protocols, slow feedback loops, and disjointed technology transfers quietly consume the internal bandwidth that small teams cannot afford to lose.⁷

Five Practices For Smarter CDMO Selection

Avoiding the capacity crunch starts well before you sign an MSA. The following five practices can help biotechs move from reactive outreach to deliberate, strategic CDMO selection.

1. Map capacity, not just capability. Understand not only what a CDMO can do but what bandwidth they actually have available. Ask directly about project backlog, technology transfer timelines, and how resources are allocated across development phases.
2. Match technical needs to demonstrate expertise. For ADC programs, confirm in-house HPAPI containment, conjugation experience, and analytical depth. For combination products, verify capabilities in container closure testing, design verification, and regulatory documentation support.
3. Evaluate cultural and operational fit. A fast-moving biotech can be quietly slowed down by a rigid, hierarchical operating environment. Identify CDMOs whose communication style, decision-making speed, and risk tolerance align with yours.
4. Do not overprioritize one-stop-shop appeal. End-to-end CDMOs are appealing in theory but can overpromise integration in practice. In many cases, a modular approach pairing best-in-class specialists for each program component delivers better technical control and faster execution.
5. Plan for the full development life cycle. Your Phase 1 CDMO may not be your commercial manufacturing partner, and that is perfectly fine. Ensure that data packages, processes, and documentation are structured for clean transfer when the time comes.

Final Thoughts

The CDMO capacity crunch is not a temporary problem. As complex, high-value biologics continue to enter the clinic, competition for specialized manufacturing space will only intensify.⁸ But not all lost time is attributable to scarcity. Much of it comes down to mismatched expectations, inadequate diligence, and the tendency to default to familiar names rather than the right ones. Biotechs that treat CDMO selection with the same rigor applied to clinical design or regulatory strategy are the ones that keep moving forward while others stall.

Before you sign your next MSA, ask yourself: Is this CDMO partner technically capable and genuinely ready to run with us? In biotech, time is not just money. It is impact, opportunity, and lives.

References

1. BioProcess Technology Consultants. Development of Therapeutic Monoclonal Antibody Products: Technical Considerations for Biopharmaceutical Development.
2. Koleng JJ, Owens DE III, Hannon K. "How The Right CDMO Partner Can Accelerate Biologics Development." Outsourced Pharma, August 2022. https://www.outsourcedpharma.com/doc/how-the-right-cdmo-partner-can-accelerate-biologics-development-0001
3. Bhakta S, et al. "Manufacturing Challenges of Therapeutic Antibody-Drug Conjugates." BioProcess International, 2023. https://www.bioprocessintl.com/emerging-therapeutics-manufacturing/manufacturing-challenges-of-therapeutic-antibody-drug-conjugates
4. BioDlink/News-Medical. "How CDMOs Drive Higher ADC Manufacturing Yields in One Step." News-Medical, January 2026. https://www.news-medical.net/whitepaper/20260109/How-CDMOs-Drive-Higher-ADC-Manufacturing-Yields-in-One-Step.aspx
5. FDA. "Application of Human Factors Engineering Principles for Combination Products: Questions and Answers; Guidance for Industry and FDA Staff." Federal Register, September 8, 2023. https://www.federalregister.gov/documents/2023/09/08/2023-19404/application-of-human-factors-engineering-principles-for-combination-products-questions-and-answers
6. Contract Pharma. "Addressing the Pain Points of Making Drug-Device Combination Products." February 2025. https://www.contractpharma.com/addressing-the-pain-points-of-making-drug-device-combination-products/
7. ProNav Clinical. "The Impact of Supply Chain Inefficiencies on Biotech Startups." September 2025. https://www.pronavclinical.com/post/the-impact-of-supply-chain-inefficiencies-on-biotech-startups
8. Frost & Sullivan. Growth Opportunities in Biologics Contract Development and Manufacturing Organizations, 2024-2029. https://store.frost.com/growth-opportunities-in-biologics-contract-development-and-manufacturing-organizations-2024-2029.html

About The Author:

Tamika Drummond, Ph.D., is the founder and CEO of 3Kinnect Solutions Inc., a consulting firm specializing in outsourcing strategy for early-stage biotech companies. With extensive experience as a cancer research scientist and former external MSAT professional at a leading biotech company, Drummond has deep expertise in CMC development, CDMO partnerships, and biomanufacturing strategy to emerging biotechnology ventures. Through 3Kinnect Solutions, she focuses on strategic CDMO selection, capacity planning, and manufacturing partnerships that enable early-stage companies to advance their programs efficiently and cost-effectively.