Ensure first-time right GMP production of gene therapies: Proven strategies for pre-clinical manufacturing and early process development

Thursday February 2nd 2023

08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET

Live30 webinars are thirty minute presentations designed to update you on the latest innovations, applications and data in a fast yet interactive format.

While the rigors of early process development (PD) and preclinical manufacturing in cell and gene therapy can appear daunting for young companies, prioritizing certain early studies, with quality pre-clinical material can mean the difference between success and failure for these highly sensitive drug products during clinical trials and commercial launch. 

Early investment in process characterization, stability, and formulation to understand an advanced therapy’s capacity for scale-up and patient administration is integral to maximizing its potential reach.

Attendees will learn:

  • How key early-stage studies can mitigate risk and prepare companies for successful regulatory submissions
  • How high-throughput capabilities are available to improve process productivity and scalability
  • Why Pilot Plant operations provide flexibility and training advantages for preclinical production
Presenter
Avi Nandi, MBA
Chief Technical Officer
Centre for Breakthrough Medicines
View Biography
Presenter
Tatiana Nanda, PhD
Senior Director, Head of Cell Therapy Process Development & Drug Product
Centre for Breakthrough Medicines
View Biography
Presenter
Charlotte Barker
Editor
BioInsights

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