The Future of

Bio/Pharmaceutical Analysis

Online Summit 2024

Now On-Demand

Speakers

20 June

Speakers

Doli Patel

Doli Patel

Senior Director

CMC

Panel

12.30 – 2.00 pm CET

CMC considerations for cell and gene therapies

Discover the latest recommendations for chemistry and manufacturing controls required to identify the potency, purity and safety of advanced therapeutic medicinal products (ATMPs). This session will cover:

  • Standards and regulatory expectations for cell-based therapies
  • CMC strategies from early through to late-stage development
  • Final product testing and characterisation, including sterility, mycoplasma and bacterial endotoxin testing.
Adiano Leuzzi with ReiThera logo

Adriano Leuzzi

Head of Process Development
ReiThera

Doli Patel

Doli Patel

Senior Director of CMC, for a major Advanced Therapy Developer and manufacturer in Europe

Daniel Pearce with Adaptimmune logo

Daniel Pearce

VP European Manufacturing and Technical Operations
Adaptimmune

Robert Scott with eXmoor logo

Robert Scott

QP and GMP Compliance Consultant
eXmoor

Scott R. Burger with Advanced Cell & Gene Therapy logo

Moderator: Scott R. Burger

Principal
Advanced Cell & Gene Therapy, LLC