Decentralized Manufacturing Sponsors Must ‘Do Their Homework’ To Impress US & EU Regulators

 
• By Eliza Slawther

Decentralized manufacturing methods for cell and gene therapies will be critical for improving patient access to treatments, but sponsors must prepare to demonstrate “comparability” with centralized manufacturing.

Lee Buckler, Boro Dropulić, Ian Gaudet, Matthew Hewitt and Lisa Kretzschmar speaking at the Cell and Gene Meeting on the Mesa 2024 (Pink Sheet)

More from Cell & Gene Therapies

More from Europe