How to Choose a Biologics CDMO: 4 Criteria That Matter the Most

Biotech How to Choose a Biologics CDMO: 4 Criteria That Matter the Most Oct 5, 2026 8:00am Biotech Knowing how to choose a biologics CDMO matters as it’s one of the most important strategic decisions any biotech or biopharma will make. The right partner can accelerate development, reduce technical and regulatory risk, and support a smoother commercialization path. The wrong one can introduce delays, increase costs, and create challenges that are difficult to resolve later.

Dr. Ralf Otto, Rezon Bio’s COO, draws on his extensive experience in CDMO operations and strategy consulting to help you make the right CDMO choice. 1.

Reliability and quality- The baselineThe number one buying factor for biotech and biopharma companies looking for a biologics CDMO is reliability and quality. Quality is essential, as it’s now a baseline requirement rather than a differentiator between CDMOs.Sponsors can measure the reliability and quality of a potential CDMO partner by assessing their number of GMP deviations and health authority inspection records, including FDA Form 483s and warning letters. It’s crucial to explore their previous record to catch any historic issues early.

“Ultimately, it’s a product that enters a patient. Quality, reliability and the track record of health authority inspections, including how many deviations, is typically the top buying factor.”-Dr. Ralf Otto2.

Price competitiveness– The differentiatorPrice competitiveness is the second most important CDMO selection criterion. This is also evident in the growing shift of FDA-approved drug contract manufacturing deals from the US to the more price-competitive Europe. In 2025, Europe secured 34 new deals, compared with only 10 for the US.Competitive pricing is only part of the COGS equation.

The greater opportunity lies in designing an efficient manufacturing process from the outset. Rezon Bio addresses three critical COGS drivers: a) titer and yield, b) material costs, and c) manufacturing productivity and efficiency. By optimizing these levers together, the objective is not simply to offer an attractive service fee, but to help clients build a competitive and scalable cost-of-goods for commercial manufacturing.“Number two is price competitiveness.

It jumped from position seven out of ten to number two, in both drug substance and fill-finish” – Dr. Ralf Otto, COO, Rezon Bio3. Technological fit and AI/Digital Readiness– The accelerant The third criterion is technological fit, and digital readiness.

A successful partnership depends on selecting a CDMO with the right scientific expertise, manufacturing technologies, and infrastructure for your specific modality and development stage. Increasingly, it also requires a partner with the digital capabilities to enable more efficient development, data-driven decision-making, and future AI-assisted process development and manufacturing. For instance, sponsors with a biosimilar program should select a CDMO with the appropriate expertise, technologies and dedicated infrastructure to maintain quality and compliance rather than one that is new to the field.

Manufacturing scale is also equally important. The optimal bioreactor capacity depends on the biologic in production, projected demand and commercialization strategy. While some programs require the flexibility to scale seamlessly from clinical to commercial manufacturing, others are best served by smaller-scale bioreactors.

Beyond scientific and manufacturing capabilities, sponsors should also evaluate a CDMO’s digital maturity. Robust digital systems, integrated data management, and advanced analytics can improve batch transparency, enable more informed real-time decision-making, and enhance process understanding throughout development and manufacturing. While AI adoption in biopharmaceutical manufacturing is still evolving, CDMOs that are investing in digital infrastructure today will be better positioned to deliver meaningful improvements in operational efficiency, process consistency, and knowledge management as these technologies continue to mature.

“Number three is scientific soundness, technological fit and digital readiness. A successful partnership starts with selecting a CDMO that has the right scientific expertise, technologies and capacity for your specific product and stage of development” – Dr. Ralf Otto, COO, Rezon BioCriterion 4: Product-oriented Ownership & Cultural fit – The confidenceSelecting a CDMO is about choosing a partner you can be confident will remain committed throughout the lifecycle of your product.

During the COVID-19 pandemic, many CDMOs entered the market to meet unprecedented demand, only to scale back operations, change ownership, or exit the market as demand normalized. For sponsors, these changes can disrupt development, complicate tech transfer, and introduce unnecessary risk into long-term programs. Sponsors should also consider whether a CDMO has a product-oriented culture, one shaped by having been in the client’s shoes.

Organizations that have developed and commercialized their own products understand the challenges sponsors face because they have experienced them firsthand. This shared perspective fosters stronger collaboration, more pragmatic decision-making, and a culture focused on long-term product success.Rezon Bio’s roots reflect this mindset. As part of an ecosystem that began with generic medicines and expanded into complex biologics, the organization has supported the development of its own products while building integrated development and manufacturing capabilities.

That experience creates a cultural fit with biotech and pharmaceutical innovators, combining the perspective of a developer with the capabilities of a CDMO. “A biologics program is a long-term commitment, so sponsors should understand not only who owns their CDMO, but also the mindset behind the organization. At Rezon Bio, we’ve developed our own biologic products, so we understand the challenges our clients face.

That product experience shapes our culture, our decision-making, and the way we partner with customers.” Dr Ralf Otto, COO, Rezon BioBleys J, Ream S, Ehlert F. How customer expectations are reshaping the CDMO market [Internet]. McKinsey & Company; 2026 Aug 3.

Available from: https://www.mckinsey.com/industries/life-sciences/our-insights/the-synthesis/how-customer-expectations-are-reshaping-the-cdmo-marketGlobalData. FDA-approved drug manufacturing deals shift to Europe, says GlobalData [Internet]. London: GlobalData; 2026.

Available from: https://www.globaldata.com/media/pharma/fda-approved-drug-manufacturing-deals-shift-to-europe-says-globaldata/ The editorial staff had no role in this post's creation. Biotech