Many hurdles to streamlined, cost-effective manufacture of cell and gene therapy products derive from a lack of standardized methodologies and training around CMC programs.
To address this, ARM and our members created a comprehensive resource for the sector. Together, we published A-Cell in 2022, an extensive case study on incorporating Quality by Design (QbD) principles into cell-based therapy CMC programs.
A-Cell emulates previous QbD efforts that were applied to the manufacturing of monoclonal antibodies (A-Mab) and vaccines (A-Vax), bringing best practices in CMC to a case study of CAR-T therapy manufacturing.
In conjunction with the A-Cell document, ARM hosted a nine-part live webinar series highlighting specific A-Cell chapters. Together, these serve as one of the most comprehensive resources for gene therapy organizations.
Access ARM’s leading resources on how to apply Quality by Design principles in cell therapy CMC program development.
A live webinar series that highlights specific chapters of A-Cell, providing a deep dive from industry experts.
ARM also has a leading resource for that! Like A-Cell, our A-Gene project explores how to apply Quality by Design principles in gene therapy CMC program development. View the A-Gene webpage here for more details.
Sign up for ARM’s weekly newsletter on sector news and alerts for events, reports, and other engagement opportunities.
