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How a stage-gated approach improves drug product manufacturing: Expert insight series
Go inside Accelerator™ Drug Development to discover what sets a program up for manufacturing success—and why a rigorous, stage-gated approach that connects key stakeholders from the start is essential to reducing risk.
Successful drug product manufacturing starts long before GMP stages. Early cross-functional alignment, high-quality data, and scalable process design all work together from the beginning to influence regulatory approval pathways and speed to commercialization.
According to Luca Russo, VP and General Manager of Steriles (EU and APAC), Pharma Services, Thermo Fisher Scientific, successful drug product manufacturing requires a rigorous stage-gated approach that clearly defines decision points upfront while leaving room to adapt as the science evolves.
This means connecting key stakeholders early and often throughout the journey to market, as disconnected vendors and siloed teams can create solutions that work in the short term but require rework later.
A real-world case study: How one company avoided scale-up delays
To illustrate this point, Luca shares the example of a biotech company whose small-scale process initially performed well, but during technology transfer encountered unforeseen variability and API loss. The resulting re-optimization delayed the company's IND submission and clinical study. A more integrated approach—connecting process knowledge, analytics, manufacturing, and clinical requirements from the start—could have enabled a smoother scale-up and helped avoid costly and unnecessary delays.
Watch the video to hear Luca's expert advice for drug developers preparing for manufacturing and learn how strategic integration can help overcome common challenges. You'll also gain insights into the following key takeaways from his decades of experience.
Key takeaways to help ensure successful drug product manufacturing:
- The most common mistakes sponsors make in drug product manufacturing
- How an integrated development approach reduces risk and avoids rework
- Why optimizing for the full development journey delivers better outcomes
- The value of connected workflows across development and manufacturing
- A case study on how one biotech company overcame scale-up challenges
Expert:
Luca Russo, Vice President/General Manager of Steriles (EU and APAC), Pharma Services, Thermo Fisher Scientific
Luca Russo is Vice President/General Manager, Steriles EU & APAC at Thermo Fisher Scientific. His perspective connects development strategy with the manufacturing requirements needed to support programs as they progress toward commercialization. He focuses on robust, scalable manufacturing processes, effective technology transfer, and early alignment across process development, analytics, manufacturing and clinical requirements.
This is part of a larger series, “Expert Perspective: Inside Accelerator™ Drug Development.” Watch the full video featuring seven industry-leading, cross-functional experts here.