Cell and gene therapy products have only been around a short time. Yet the market for these products continues to climb exponentially. In fact, currently, 18 cell and gene therapy products have been approved FDA and over 37,000 clinical trials for cell therapies are listed on clinicaltrials.gov.

These products have the potential to effectively treat a number of medical conditions from cancer to genetic disorders to rare diseases.

Yet compared to traditional large and small molecule manufacturing, cell and gene therapy products face unique challenges. Smaller batch sizes, quicker administration, specialized supply chain requirements, and the need for more up-to-date regulatory guidance are some of the challenges facing manufacturers in this area.  

How can manufacturers address these challenges to ensure the development and production of life-saving products?

On Tuesday, Sept. 29, Govzilla hosted a webinar covering, CMC Considerations for Cell and Gene Therapy Products, featuring Pharmatech Associates’ Adam Lambert. In this one-hour webinar, he presented the challenges and opportunities facing cell and gene therapy manufacturers.

To download the webinar, click here.

What You Will Learn

  • How to establish a comprehensive continuous process verification plan
  • The post-marketing commitments of cell and gene therapy products
  • Case studies of how companies resolved production issues

Who Will Benefit

This session will be valuable to anyone involved in the development and manufacturing of cell and gene therapies and looking for clarification on CMC issues.

About the Presenter

Adam Lambert has over 20 years of experience in drug and device development, including Quality by Design, CMC strategies, formulations, upstream and downstream processes, and analytical methods. Currently, Adam is the Vice President of Product and Process Development at Pharmatech Associates.

To download the webinar, click here.

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