BIO
Viral therapeutics present unique manufacturing challenges that make CDMO selection far more complex than for highly platformed biologics. With modalities such as AAV, lentiviral vectors, viral-vector vaccines, and oncolytic viruses each requiring distinct manufacturing, analytical, and scale-up approaches, developers need partners capable of managing technical uncertainty, adapting processes across development stages, and supporting long-term program growth. Successful CDMO selection depends not only on current capabilities, but on the organization's ability to transfer technology, evolve analytical methods, scale manufacturing, and maintain product quality throughout development.
In this article, we explore the key considerations for selecting a viral CDMO that can support a program from early development through commercialization. The paper examines how relevant viral manufacturing experience enables risk identification and problem-solving, why technology transfer and analytical readiness are central to successful scale-up, and how quality systems, project management, organizational continuity, and strategic expansion planning influence long-term success. It also highlights the value of integrated manufacturing networks that help preserve knowledge, reduce interfaces, and support evolving clinical and commercial requirements.
What you'll explore
- Why viral modalities require a different approach to CDMO selection than traditional biologics manufacturing
- How relevant viral manufacturing experience enables pattern recognition, risk identification, and more effective problem-solving during development
- The critical role of technology transfer in adapting processes to new equipment, facilities, scales, and GMP environments
- Why process development and analytical readiness must advance together to support comparability, potency assessment, and product quality
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