Every second counts: what real cell and gene therapy launches teach us
For cell and gene therapies (CGTs), the path from a successful clinical readout to reliable commercial supply remains one of the most technically and operationally demanding transitions in the pharmaceutical industry. The final 24 months before launch is a critical window that is still often underestimated by the teams navigating it. During this period, processes must become robust and scalable, tech transfer and validation must be completed, manufacturing capacity secured, and supply chains prepared to support commercial demand.
This webinar covers the practical aspects of preparing for CGT commercial approval and manufacturing, based on real lessons from launched programs. The session will be delivered by Lonza’s Global Head of Launch Excellence and Digitalization for Specialized Modalities.
If commercialization is part of your roadmap, whether you are early in development or already planning late-stage manufacturing, this webinar will help you prepare for the realities of commercial manufacturing and supply.
Learning points:
- Understanding the transition from clinical to commercial manufacturing, including process robustness, validation, and GMP expectations.
- Practical insights into tech transfer and scale-up challenges and how to avoid common late-stage delays and comparability risks.
- Key operational priorities in the final 24 months before launch, including raw materials, vector supply, capacity, and supply chain planning.
- How to prepare processes for commercial scale and cost of goods, including automation and process industrialization.
FAQ answered in webinar
Why are the final 24 months before CGT launch so critical?
The final two years before launch are where cell and gene therapy programs transition from clinical success to commercial reality. During this phase, companies must prove that their manufacturing process is robust, scalable, and inspection-ready. Many launch delays are not caused by clinical performance, but by manufacturing, quality, and CMC challenges that emerge late in development.
What are the biggest challenges when moving from clinical to commercial manufacturing?
Commercial manufacturing requires a completely different level of control and coordination. Processes that work at clinical scale often rely on manual interventions or flexible workflows that are not sustainable for commercial supply. Companies must improve process automation, strengthen analytics, secure raw material supply, and prepare facilities and teams to consistently manufacture at higher volumes.
Why is early commercialization planning so important?
Decisions made early in development can create major bottlenecks later. Open handling steps, slow analytical methods, or non-scalable process designs may require significant rework before launch. Addressing scalability, automation, and supply chain readiness early helps avoid costly delays and reduces the risk of comparability studies or regulatory setbacks closer to approval.
How does digitalization support commercial readiness?
Digital tools become essential as therapies scale from a handful of batches to thousands per year. Electronic batch records, automated data collection, and integrated dashboards improve data integrity, accelerate batch release, and provide better visibility across manufacturing operations. Digitalization also enables faster decision-making and smoother collaboration between CDMOs and therapy developers.
What makes a successful CDMO partnership during commercialization?
Successful commercialization depends on close collaboration between the therapy developer and CDMO. Cross-functional coordination across manufacturing, quality, analytics, supply chain, and regulatory teams is critical. Transparent communication, shared governance, and experienced commercialization leadership help identify risks early and keep programs on track for approval and launch.
