The Case For CGT In-House Manufacturing
By Erin Harris, Editor-In-Chief, Cell & Gene
Follow Me On Twitter @ErinHarris_1
On a recent episode of Cell & Gene: The Podcast, Sangamo Therapeutics’ EVP Head of Technical Operations, Andy Ramelmeier, joined me to talk about why the Brisbane, CA-based biotech built its own Phase 1/2 cGMP AAV in-house facility. Ramelmeier broke down what drove the decision to build, the major considerations he and his team faced when building the facility, etc. Fast forward to today. He explained how the decision to build will affect the company’s ability to accelerate from early stage to future commercialization. Because as we know, the cost of manufacturing is staggering. And so, Ramelmeier covered the top challenges facing cell and gene therapy manufacturing as well as some of the potential and realistic solutions driving down manufacturing costs.
On a different but equally valuable episode of Cell & Gene: The Podcast, I invited Kite Pharma’s Head of Manufacturing Quality, Will Junker, to join me to discuss the challenges associated with capacity planning, whether to partner with a CDMO, and why it's important to prioritize inventory over time-to-market. Junker provided insight on why standardized CMC methods are important by explaining what those methods are, and if developing standardized methods is feasible for most CGT companies any time soon. Because viral-vector manufacturing is not standardized across the industry, with biopharma companies using different production systems and downstream processes, Junker shared his insight on why this is so. And he shared valuable information regarding capacity planning.
Ramelmeir, Junker, and I are teaming up, this time for a full-scale virtual roundtable. Indeed, on May 4, 2023 at 12 p.m. EST, our Cell & Gene Live, Building An In-House Cell & Gene Manufacturing Facility - Best Practices Lessons Learned, will be a detailed discussion about building an in-house manufacturing facility. If you and your team are knee-deep in the build versus buy debate, or if you want to learn from industry luminaries who can speak directly to the topic, you really need to tune in. The recent market downturn has most certainly impacted cell and gene therapy's build versus buy debate. Yet, with flexible and sustainable design strategies and best practices and contingency planning based on current market conditions and exit strategies, building an in-house facility is feasible.
We’ll be taking audience questions in real time during the live 60-minute Cell & Gene Live, Building An In-House Cell & Gene Manufacturing Facility - Best Practices Lessons Learned. But if you have questions or topics you’d like us to consider as we craft our discussion and research and prepare our talking points, please feel free to email your questions to me directly. Our goal is to target as many of your questions as possible. Registration is free, so register today. I hope to see you there.