Michael Lehmicke, Senior Director of Science & Industry Affairs, Alliance for Regenerative Medicine, Washington, D.C., discusses the importance of generating and adhering to best practices and standards in cell and gene therapy (CGT) manufacturing. Mr Lehmicke explains that a major issue in the CGT industry is disagreement on best manufacturing practices. He outlines some of the efforts being made by ARM to tackle this problem, highlighting the A-Gene and A-Cell projects which aim to describe the application of quality by design to the development of CGT products. This interview took place at Advanced Therapies Week 2022.
Michael Lehmicke is the Senior Director of Science & Industry Affairs at Alliance for Regenerative Medicine.