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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)

While cell and gene therapies can prove life-changing for patients and are increasingly entering major markets including the EU and US, sponsors continue to face a litany of hurdles when it comes to delivering them to patients.

Manufacturing is one of the key issues faced in the cell and gene therapy space. During a panel discussion on 7 October at the Alliance for Regenerative Medicine’s Cell and...

Key Takeaways
  • Decentralized manufacturing approaches can make cell and gene therapies more accessible by reducing the travel burden on patients.
  • However, sponsors must be...

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