How to Choose a Biologics CDMO?
Advanced GMP services and technology
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.
How to Choose a Biologics CDMO: The 4 Selection Criteria According to Ralf Otto, CDMO Operations Expert and Rezon Bio’s COO
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.
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.
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 DifferentiatorAccording 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.
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
Full article: https://rezonbio.com/how-to-choose-a-biologics-cdmo-the-4-selection-criteria-according-to-ralf-otto-cdmo-operations-expert-and-rezon-bios-coo/
