How to Standardize Advanced Therapy Manufacture
Cell and gene therapy manufacturing technologies and methods are advancing rapidly, but can regulators keep up? Given the uniqueness of each product, what will it take to make high standards and best practices a reality across the board?
James Strachan | | Longer Read
“My name is Angela Myers and I lead a new business initiative in gene editing and cell and gene therapy (CGT) manufacturing at Merck. In this role, I am responsible for R&D, commercial, marketing, strategy functions for the viral vector CDMO business, and the CGT manufacturing technologies such as cell lines and acoustic cell therapy manufacturing.”
“Hello, I’m Michael Lehmicke, the Director of Science and Industry Affairs at the Alliance for Regenerative Medicine. ARM is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines – cell, gene, and tissue-based therapies. My role at ARM is to work with our members to identify best practices for establishing robust manufacturing processes. We also work collaboratively to identify CMC guidance gaps. We have a good working relationship with the FDA and EMA and engage with both regulators regularly to address these gaps.”
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