Viral Vector Production: How CDMOs Influence Late-Stage Development Success

By Sam Wood, Senior Director of Commercial Development for Viral Vectors, and Suparna Sanyal, Director of Commercial Development, CGT Viral Vector

Although only 24 viral vector-based gene therapies have been approved, hundreds of candidates are progressing through clinical development. At the same time, high-dose fatalities and manufacturing variability have contributed to increased regulatory scrutiny, raising the stakes for programs approaching commercialization. At this stage, resolving deficiencies can be costly and time-consuming, leaving developers with limited opportunities to recover from setbacks.

In this article, Sam Wood, Senior Director of Commercial Development for Viral Vectors, and Suparna Sanyal, Director of Commercial Development for Viral Vectors, both within Lonza’s Specialized Modalities business, examine the challenges that can complicate late-stage development and commercial readiness. They discuss common pressure points in biologics license application (BLA) submissions, technology transfer, and maintaining production continuity. The conversation also addresses market volatility, a factor that can affect both developers and contract development and manufacturing organizations (CDMOs) but remains largely outside their control. Beyond these risks, Wood and Sanyal consider what comprehensive life-cycle experience looks like in a manufacturing partner and why it matters as programs move from development toward commercial supply.

Read the full article to explore their perspectives on navigating late-stage viral vector manufacturing challenges and the capabilities they believe distinguish an experienced CDMO partner.