CMC Expertise Accelerating Biologics Development for 20 Years and Counting

Working with my co-founders, colleagues, and clients on many fascinating projects over the last twenty years has been an honor. From the founding of the firm with former Pfizer colleagues until today, we have specialized in supporting the CMC and regulatory programs...

Key Considerations in Gene Therapy Manufacturing for Commercialization

“The regulatory landscape for gene therapies is as transforming as the curative nature of a transgene. In 2012, we saw the introduction of the Breakthrough Therapy Designation. Just when you thought cooperation from FDA couldn’t get any better, the Regenerative Medicine Advanced Therapy (RMAT) designation was introduced in December 2016 through the 21st Century Cures Act. These designations have exponentially changed the course of drug development and the regulatory review process for the treatment of patients. Within this era of divisive politics, we should all agree on one thing – job well done Congress.”

– Tracy TreDenick, Head of Regulatory and Quality, and Senior Consultant, BioTechLogic

These insights from Tracy are just a peek inside the new eBook released by The Cell Culture Dish. Tracy and 12 other industry experts collaborated to release the piece entitled Key Considerations in Gene Therapy Manufacturing for Commercialization. This piece offers both background and a look to the future as gene therapies continue to make an incredible impact on the therapeutic landscape including a great deal of promise on the horizon.

Download the Whitepaper