Unlike traditional drug products, gene therapy products differ when it comes to manufacturing, creating challenges. Smaller batches. A limited pool of suppliers. The need for quicker analytical tests. These gene therapy manufacturing challenges must be factored in when it comes to adhering to regulations. How are FDA investigators responding to these challenges and what are their top concerns?
If you are a gene therapy manufacturer, check out these resources:
Data Integrity Concerns Discovered in Gene Therapy Product Submissions
Find out why data integrity issues drew reviewers’ concerns when it came to three product submissions.
FDA Addresses Cell and Gene Therapy Manufacturing Challenges
Learn more about the cell and gene therapy FDA inspection landscape from an FDA investigator.
FDA Takes Quality Systems Approach to CGT Inspections
What are some common FDA observations when it comes to inspections of gene therapy manufacturing sites?
CBER Director Wilson Bryan On How To Cut CGT Product Approval Times In Half
By resolving potential gene therapy manufacturing challenges early on, product approval times can be cut in half, according to one FDA regulator.
Overcoming CMC Complexity for Cell & Gene Products
Why are test methods a challenge with cell and gene therapy products?
Webinar | CMC Considerations for CGT Products
Watch this webinar recording featuring Pharmatech Associates’ Adam Lambert and see how cell and gene therapy manufacturers are addressing manufacturing challenges.
Gene therapy manufacturers are invited to try out Redica Systems for free. See how Redica Platform allows you to quickly assess inspection records including dates and inspectors across all of your sites.
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