Setting The Stage For Successful Clinical Manufacturing Of Cell And Gene Therapies

When it comes to the clinical manufacturing of cell and gene therapies, many early-stage biotech companies fall prey to a common pitfall: overestimating their readiness. There are many areas you need to consider when judging the readiness of your product to move to the manufacturing phase — from scalability and repeatability to the very team you’re working with. Establishing a clear understanding of knowing what to look for when determining if your product is GMP-ready is also difficult, especially for relatively inexperienced companies. The pressure from patient populations and stakeholders also cannot be overlooked as a factor driving companies to overestimate their readiness.

The best way to learn how to navigate these challenges and avoid overestimating your readiness is to hear from those who have gone before you, which is why we have compiled the vital insights of industry experts who have seen and done it all before. Review these lessons to gain insights on how to ensure quality, improve patient access, and reduce the cost of manufacturing. By discovering the things you don’t know, you will gain the knowledge needed to objectively assess your product’s GMP-readiness and save time and money along the way.