Knowing how to choose a biologics CDMO matters as it’s one of the most important strategic decisions any biotech or pharma company will make. The right partner can accelerate development, reduce technical and regulatory risk, and support a smoother path to commercialization. The wrong one can introduce delays, increase costs, and create challenges that are difficult to resolve later in the program.
Dr. Ralf Otto, Rezon Bio’s COO, draws on his extensive experience in CDMO operations to help you make the right choice and identify any potential red flags.
Read on for the four biologics CDMO selection criteria and the questions to ask before you commit.
Key Takeaways
The four main biologics CDMO selection criteria are:
- Reliability and quality (the baseline): inspection history, quality systems, deviation trends, and compliance track record
- Price competitiveness (the differentiator): fee-for-service vs. full value picture
- Technological fit and AI/Digital readiness (the accelerant): scale, modality, expertise match, AI/data-driven capabilities that enable faster, smarter development and manufacturing
- Product-oriented ownership and cultural fit (the confidence): stable, long-term ownership and a partner shaped by its own product development experience
Biologics CDMO Selection: A High-Stakes Choice
A CDMO partnership for a biologics program is a multi-year, high-dependency relationship that impacts every aspect of a drug’s journey from conceptualization and development to regulatory filing and commercialization. As a result, selecting the right CDMO partner for your specific requirements is crucial to a program’s end-to-end success in providing biologic therapies to patients who need them. Get this first selection stage wrong and timelines, budgets, and programs can suffer.
Yet many biotech sponsors evaluate biologics CDMOs on broad, surface-level criteria like reputation, price, and a reference call, rather than the operational factors that determine whether a batch is delivered on time, a tech transfer succeeds, and the relationship holds up when unforeseen challenges arise.
This article draws on extensive real-world industry insights from our COO, Dr. Ralf Otto, and reflects changing customer expectations within the CDMO market, according to McKinsey & Company.1 The aim is to provide sponsors with a structured, four-pillar framework for their next CDMO evaluation.
What Are the Biologics CDMO Selection Criteria?
Criterion 1: Reliability and Quality – The Baseline
The number one buying factor for biotechs or pharma looking to partner with a biologics CDMO is reliability and quality, as indicated by Dr. Ralf Otto’s CDMO consulting experience. McKinsey & Company agrees that quality is essential, and it is now a baseline requirement rather than a differentiator between CDMOs.1
In practical terms, sponsors can measure the reliability and quality of a potential CDMO partner by assessing their number of Good Manufacturing Practices (GMP) deviations and health authority inspection records, including FDA Form 483s and warning letters. It’s crucial to explore their previous record, not just their current approval status to catch any historic issues early. Search for FDA warning letters here.
“Number one is reliability and quality. Ultimately, it is a product that enters a patient. Quality, reliability, and the track record of health authority inspections, including how many deviations, and so on, is typically the top buying factor.” – Dr. Ralf Otto, COO
Ask: “Can you share your last three FDA and EMA inspection outcomes and the deviation trend over the past two years?”
Criterion 2: Price Competitiveness – The Differentiator
According to Dr. Ralf Otto, price competitiveness is now 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.2 McKinsey & Company research also indicates that ‘rising cost sensitivity among customers’ is reshaping the competitive landscape, and that cost now ranks second among all buying factors, becoming a major differentiator.1
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.
If your potential CDMO choice is price-competitive, it does not mean it compromises on regulatory authorization, a highly qualified workforce, stable ownership, or long-term vision. These criteria should be considered as a whole to provide insights into the full value a CDMO can deliver as a partner while highlighting any gaps.
“Number two is price competitiveness. It really jumped from position seven out of ten to number two. Price competitiveness came up extensively in both drug substance and fill-finish.” – Dr. Ralf Otto, COO
Ask: “How does your pricing compare with the market, what services are included and how do you help optimize the total development and manufacturing costs?”
Criterion 3: Technological Fit and AI/Digital Readiness – The Accelerant
The third criterion in Dr. Ralf Otto’s recommendation is scientific soundness, 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 stage of development. 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. The McKinsey & Company report defines digital and AI-enabled operations as the accelerant that will provide both cost and reliability advantages.1
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. The same principle applies across biologics. Choosing a partner with relevant analytical expertise and technical experience in your molecule class reduces development risk, minimizes process optimization later in the program, and helps avoid unnecessary costly delays during tech transfer and manufacturing.
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. The right capacity should align with both the molecule’s characteristics and long-term manufacturing strategy.
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 within a highly regulated environment, 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.
Increasingly, sponsors should also look for strong digital capabilities that improve transparency, support data-driven decision-making, and enable more efficient collaboration and technology transfer. For instance, in terms of scale, Rezon Bio is currently at a 500- to 4,000-liter capacity, soon to be up to 12,000 liters. However, not every program requires larger capacity. Some molecules with high expression are ideally suited to 500 liters, while others require 15,000- to 20,000-liter scale from the beginning. That’s why it’s essential to assess a CDMO’s scientific expertise, technology platform, digital maturity, and capacity early to ensure the right fit for your program.” – Dr. Ralf Otto, COO
Ask: “What is your current utilization at the scale my program requires? What experience do you have with my molecule class and modality? How are you investing in digital technologies to improve development and manufacturing performance?
Criterion 4: Product-Oriented Ownership & Cultural Fit – The Confidence
Selecting a CDMO is not only about capabilities today. It is also about choosing a partner you can be confident will remain committed throughout the lifecycle of your product. The CDMO that exists today may not exist, or may not be the same organization, when a program reaches its commercial phase. If this happens, it can be challenging to navigate program transfer and can delay the pipeline significantly.
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, as Dr. Ralf Otto states. For sponsors, these changes can disrupt development, complicate tech transfer, and introduce unnecessary risk into long-term programs.
Beyond financial stability, 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.
“Number four is product-oriented ownership and cultural fit. 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. Combined with stable, long-term ownership, it gives sponsors confidence that we are invested in their success for the entire lifecycle of their program.” – Dr. Ralf Otto, COO
Ask: “Who owns you, and what is their stated long-term commitment to this business?”
Making the Right Decision When Choosing a Biologics CDMO
Choosing a biologics CDMO is one of the most important strategic outsourcing decisions that shapes a program’s trajectory for years. Together, Dr. Ralf Otto’s four biologics CDMO selection criteria provide a core framework to help biotech and biopharma make the most informed decision possible. Considerations span reliability and quality as the baseline, price competitiveness as a differentiator, technological fit paired with digital readiness as the modern accelerant, and product-oriented ownership for partnerships that inspire confidence. No criterion exists in isolation, and you should evaluate all four together. A CDMO that’s price competitive but lacks a credible inspection record or isn’t digitally optimizing operations to remove inefficiencies could carry risk that surfaces down the pipeline.
Looking to partner with a product-oriented biologics CDMO that meets all of our selection criteria? Talk to us about how we’d approach your program’s timeline and requirements.
References
- Bleys 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-market
- GlobalData. 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/
