Forge recently co-hosted a webinar with Endpoints News, where our leaders and industry gene therapy experts shared valuable insights on key considerations when choosing a CDMO. The webinar, titled "7 Questions Gene Therapy Developers Should Ask Their CDMO (and What They Will Ask you!)" delved into topics such as yield, commercial readiness, scale-down models, automation of analytical assays, and more.
During the webinar, Forge's CTO David Dismuke, Ph.D., and CCO John Maslowski were joined by Karen Kozarsky, Ph.D., Chief Scientific Officer of SwanBio and Jenny Holt, Chief Development Officer at Ray Therapeutics, to answer these seven critical questions:
- As a client, what are some of your early thoughts and considerations when deciding to go with a CDMO (buy vs. build) and what is on your RFP checklist?
- Biggest question for CDMOs – “what’s my yield?” Help us break down what the gold standard is in evaluating yields and titers. How can you compare apples to apples across CDMOs?
- What drives early manufacturing decisions when determining whether to execute a high process development needed campaign or to employ a platform approach? Is something different if you’re using a novel capsid. Does that change your approach?
- Talk to us about engineering runs – worth it?
- Are there “right” scale up methods, and how high can we go without significant impact on per L titer? Going the other direction: what are the advantages of having a qualified scale-down model to process development and Biologics License Application (BLA) characterization?
- If a previous product was produced using an adherent platform, what steps can be taken to migrate to a suspension system? What do comparability studies look like for such an approach?
- The common response to “when should I start thinking about my commercial manufacturing plans?” is typically “as early as possible.” However, what early steps should an early-stage biotech startup take to prepare?
To hear their insightful answers to these questions and the robust audience Q&A you can watch the webinar here.
This webinar highlighted the vital relationship between gene therapy developers and the CDMO partners they select to help advance innovative therapies and reach patients in need. At Forge, we see ourselves as partners in this endeavor and look forward to helping bring our clients' missions to life.