CDMOs
Choose your partner wisely!
Jakub Knurek, Marketing Specialist, Mabion S.A.
Maryam Daneshpour, Business Development Expert ASA Kimyasal
Choosing the right CDMO is critical for biotech and pharma success. This decision involves evaluating hidden factors like scalability, quality systems, and certifications. Companies must navigate trade-offs between specialized and large-scale CDMOs, identify red flags, and negotiate alignment in technology, transparency, and values to ensure project success and long-term collaboration.
1. From your perspective as a CDMO expert, how has the role of CDMOs evolved in the biotech and pharma industries over the past decade?
JK: Over the past decade, the role of a contract development and manufacturing organisation (CDMO) in the biotech and pharma industries has undergone a profound transformation. No longer seen as mere service providers, they have become strategic partners, playing an integral role in the success of drug development and manufacturing. Today’s CDMOs are involved throughout the entire lifecycle of drug development, from early-stage R&D and process development to commercial scale. Their involvement now spans from early development to commercial manufacturing, integrating technological expertise, flexibility, and regulatory compliance to drive project success.
2. What are the less obvious but critical factors companies should assess when choosing a CDMO, such as their internal quality culture or problem-solving approach?
JK: When choosing a CDMO, in addition to standard considerations such as capacity, cost and compliance, flexibility should also be considered. A factor such as a solution-oriented approach to problem solving can make a significant difference in achieving positive collaboration outcomes. Challenges in our industry inevitably arise. A solution-oriented mindset and a can-do approach can allow you to minimise the negative impact of changes on your process, while a proactive partner allows you to adapt quickly to new market conditions.
3. What are some red flags that biotech and pharma companies should look out for during the evaluation process of potential CDMO partners?
JK: One of the most significant red flags is a misalignment in priorities, values, or project goals. A strong partnership requires both parties to share a clear understanding of the objectives, timelines, and quality expectations. If a CDMO shows reluctance to adapt its processes to meet the specific needs of your project or prioritises their own operational convenience over collaboration, it is a sign of poor alignment.
The case is similar with unprofessional cooperation agreements. This is one of the easiest red flags to spot. Proposals that rely heavily on generalised statements without actionable details should prompt further scrutiny of the CDMO’s capabilities and readiness. A credible partner presents a comprehensive and transparent proposal that addresses every aspect of the collaboration, including anticipated challenges, mitigation strategies, and contingency plans. In this regard, an understanding of the document assumptions by both parties is mandatory.
Last but not least, the state of a CDMO’s facilities and systems is another key area to evaluate. During site visits, if the manufacturing or development facility appears disorganised, poorly maintained, or understaffed, it raises serious concerns about the ability to handle your project with care and consistency. Similarly, outdated equipment, a lack of automation, or insufficient data management systems may signal an inability to keep up with industry standards.
4. How do smaller, specialised CDMOs compare to large, full-service CDMOs in terms of flexibility, focus, and client satisfaction?
JK: I believe there is enough room in the market for both smaller specialized CDMOs and larger bio harvesters that don’t take such a personalized approach to the customer.
Smaller, specialised CDMOs offer flexibility and deep technical focus, making them ideal for niche projects, while large CDMOs excel in scalability and global reliability. Smaller firms provide personalized service and adaptability, while larger ones ensure robust processes and consistent capacity. The choice depends on the project’s complexity and growth potential.
5. How can certifications, such as GMP, ISO standards, or country-specific regulatory approvals, serve as indicators of a reliable CDMO?
JK: Certifications like GXP and ISO standards provide tangible evidence that a CDMO is committed to quality, consistency, and regulatory compliance. GMP compliance, for example, assures that the CDMO follows protocols designed to prevent contamination, ensure traceability, and guarantee batch-to-batch consistency. This is critical in pharmaceutical manufacturing, where even minor deviations can lead to significant medical consequences. From a business perspective, these certifications reduce risks related to quality failures and regulatory delays.
Additionally, obtaining approvals from major regulatory authorities like the FDA, EMA, or PMDA requires CDMOs to meet stringent global standards. They demonstrate adherence to global standards and readiness for inspections by authorities.
6. How important is a CDMO’s investment in cutting-edge technologies, and how can companies assess whether they are benefiting from such advancements?
JK: There are a great many areas in pharma where innovations can be implemented. However, it is important to ensure that they are in line with regulatory guidelines and aligned with the project goals. For instance, the adoption of single-use systems can minimise contamination risks and accelerate changeovers between products, providing greater flexibility for multi-product facilities. These innovations reduce timelines, improve yields, and ensure competitive advantage.
The evolution of the pharmaceutical industry has mirrored the industrial revolutions - from the mass production of essential medicines to today's era of personalized healthcare. CDMOs are leveraging virtual partnerships to streamline drug development processes, enhance flexibility, and accelerate timelines.
Pharma 5.0 enables real-time monitoring, predictive analytics, and process optimisation, ensuring consistent quality and faster problem resolution. For customers, this means reduced time-to-market, enhanced scalability, and improved product reliability. By leveraging Pharma 5.0, CDMOs can offer tailored, data-driven solutions that align more closely with client goals, creating a collaborative and future-ready partnership.
7. How does a CDMO’s geographic location impact regulatory approval timelines, supply chain logistics, and overall project costs?
JK: The most reputable agencies for pharma regulation are the EMA and the FDA. The location of CDMOs under their jurisdiction gives customers confidence that products manufactured at their facilities will meet the highest international quality standards. The presence of Biosecure Act and mutual recognition agreements between the EMA and the FDA make them speak with one voice. From my observations, the FDA is slightly faster in approving new therapies, but the EMA's delay is marginal.
In terms of supply chain logistics, I think the key is that the Pacific is a very vast, empty area. The economic Eurocentrism caused by this allows efficient access to key markets in both America and Asia. The region also boasts well-developed infrastructure, including advanced transportation networks and reliable cold chain solutions, ensuring the timely and secure delivery of critical raw materials and finished products.
When considering overall project costs, CDMOs located in Asia definitely stand out in the market. However, pharmaceutical companies are very cautious about outsourcing projects in the region. While manufacturing costs in regions such as China and India may initially seem very attractive, the potential volatility of regulatory challenges and quality systems can introduce hidden costs and risks. Europe strikes a balance between the higher operating costs typically associated with US-based CDMOs and the cost efficiencies often sought in Asia. European CDMOs provide a cost-effective solution that doesn’t compromise on quality or regulatory compliance.
8. What key performance indicators (KPIs) should companies establish with their CDMO to ensure accountability and success throughout the project lifecycle?
JK: To ensure accountability and success in a CDMO partnership, establishing clear and relevant KPIs is essential. These metrics provide measurable benchmarks that both parties can track throughout the project lifecycle, promoting transparency, quality, and efficiency.
KPIs can address various aspects of working with CDMOs. Among the most common are indicators assessing the efficiency of manufacturing process and product performance (batch success rates, process cycle times, and yield percentages compared to targets), regulatory compliance (batch deviations, deviation closure timelines, batch rejection rates, and CAPA effectiveness), and project timeliness (on-time delivery rates, and percentage of milestones achieved on schedule).
9. How important is it for a CDMO to have prior experience with similar product types, and how can this impact project success?
JK: Prior experience with similar product types reduces learning curves, ensures regulatory familiarity, and enhances risk management. CDMOs with relevant expertise offer refined processes and anticipate challenges more effectively. This experience streamlines development, scale-up, and compliance, ensuring smoother outcomes. A CDMO’s experience with similar product types acts as a catalyst for efficiency, risk reduction, and regulatory success.
10. How can CDMOs tailor their services to meet the unique needs of smaller biotech startups compared to large pharma companies?
JK: For smaller biotech startups, the focus should be on offering personalised, agile, and collaborative support. These companies typically operate with limited internal resources, so a CDMO that can provide end-to-end services, including process development, analytical support, regulatory consulting, and clinical supply, is invaluable. Startups benefit from a CDMO that doesn’t just execute tasks but acts as a strategic partner, offering insights and expertise to guide them through complex development pathways. This might include advising on process optimisation, risk assessment, and regulatory strategies, helping them navigate uncertainties and avoid costly missteps.
In contrast, large pharmaceutical companies typically require a different approach. These organisations often seek high-capacity, large-scale manufacturing capabilities to support global supply chains. For them, consistency, scalability, and rigorous adherence to global regulatory standards are paramount. CDMOs serving large pharma need to demonstrate robust quality management systems, extensive capacity, and the ability to meet stringent timelines for commercial production. The partnership tends to be more transactional, with defined processes and clear deliverables, and less reliant on the strategic guidance that smaller firms require.
11. Any other comments?
The CDMO market is highly competitive. I extremely appreciate and advocate the adaptation of a "one-stop-shop" concept for the needs of the biopharmaceutical industry, from initial gene sequencing, Drug Substance manufacturing, Drug Product finishing and final medicine licensing. The integrated end-to-end approach allows for seamless coordination at all stages of drug development and ensures efficiency, quality and regulatory alignment. Typically in such cases, companies offer flexible offerings, allowing clients to choose a comprehensive solution that covers every aspect of biologic drug development, or to select customised services that best fit their unique project requirements. Special care must be taken to ensure that all services are provided with full regulatory support, as this warrants compliance with all applicable EU and US regulations. I believe that executing projects with as few subcontractors as possible, following a lean philosophy, will bring new drugs to market in the fastest way.
Author Bio
Jakub Knurek is a business development expert specializing in CDMO operations with biopharma scientific background, currently serving as a marketing specialist at Mabion S.A. During COVID-19 pandemic he has contributed to Novavax protein vaccine development. Mr. Knurek has also participated in industry discussions, such as the "Building the Future Pharma Workforce" panel at CPHI Milan 2024.
Maryam Daneshpour is a biotechnologist specializing in biopharmaceuticals and biosimilars. With over five years of industry experience in R&D and quality control, and three years in business development, she blends scientific expertise with strategic vision to expand her network and drive innovative solutions in pharma and the biotech industry.
