ARM spent nearly four years on a mission to answer the question, “What is the biggest challenge to cell and gene therapy Chemistry, Manufacturing, & Controls (CMC), and how can ARM address it?”
Many of the hurdles to the streamlined, cost-effective manufacture of cell and gene therapy products derive from a lack of standardized methodologies and training around CMC programs. To solve this challenge, ARM and our members set out to create a comprehensive resource for gene therapy professionals.
Borrowing from the ‘A-Mab’ model created for the monoclonal antibody sector, ARM and our members produced a flagship publication called A-Gene in 2021. The document is a thorough case study-based guide to integrating Quality by Design (QbD) principles in gene therapy CMC programs.
In conjunction with the A-Gene document, ARM also hosted a six-part live webinar to further unpack specific topics covered in A-Gene, culminating in a half-day virtual workshop in June 2022.
Access ARM’s leading resources on how to apply Quality by Design principles in gene therapy CMC program development.
A live webinar series that highlights specific chapters of A-Gene, providing a deep dive from industry experts.
ARM also has a leading resource for that! Like A-Gene, our A-Cell project explores how to apply Quality by Design principles in cell therapy CMC program development. View the A-Cell webpage here for more details.
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