Cell & Gene Therapy

Overview

Formed in 2018, Cell & Gene Therapy (CGT) supports the quest for better and faster development of cell and gene therapies. In this collaboration, we connect drug development and contract manufacturing organizations with the aim of ensuring harmonization and alignment around issues such as potency assays, phase-appropriate guidance for critical quality attributes, operator safety, regulatory guidelines, and C&GT-specific validation issues, as well as working towards resolving the current challenges to commercializing C&GT products.

The business of cell and gene therapy is as diverse as the patients which it serves and for that there is no one size fits all solution.

Workstreams

CGT members have identified seven precompetitive common interest challenges, addressing these challenges will help to avoid multiple industry solutions.

 

  • High Level Analytics
  • Regulatory Strategy
  • Commercialization
  • Validation
  • Raw Materials – sourcing, quality and volume
  • Environmental Health and Safety, Biosafety
  • RNA as a Therapeutic & a Gene-editing Tool
0

workstreams

0

F2F / virtual meetings

400

active participants

0

member companies

biophorum icons biophorum icons file icon 18
0

publications and presentations

Cell & Gene Therapy case study

Leveraging the CGT process maps

Current technology for cell and gene therapies (CGTs) is unsuitable for large-scale production This is partly because there is no common standard for the industrial manufacturing of CGTs….

Read More

CGT environmental health and safety

The rapidly expanding field of cell and gene therapies (CGT) could revolutionize curative treatments. Regulatory guidance has been developed to address manufacturing guidelines and CMC specifications for CGT drug products….

Read More

"*" indicates required fields

Name*
Consent*
You can view the full privacy policy here
This field is for validation purposes and should be left unchanged.