Regenerative Medicine: The Pipeline Momentum Builds
The Alliance for Regenerative Medicine, the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies, today released its H1 2022 Report. This report presents important progress for the sector throughout the first half of this year, including a record year for the approval of new gene therapies to treat rare diseases and 6 CAR-T therapies now available in the US & EU.
ARM and NIIMBL Release Project A-Cell to Bring QbD Principles to Cell Therapy Manufacturing
The Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) have released Project A-Cell, a multistakeholder collaboration to incorporate Quality by Design (QbD) principles into cell-based therapy CMC programs.
2021 was an auspicious year for the cell and gene therapy sector. ARM shared highlights from the investment, clinical, and scientific landscape, as well as a look at what’s ahead for 2022 and beyond, at the Cell & Gene Therapy State of the Industry Briefing. Following the presentation, two expert led panels discussed gene therapy for rare disease and next-generation therapies for cancer.
ARM and NIIMBL Release Project A-Gene to Bring QbD Principles to Gene Therapy Manufacturing
The Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) today released Project A-Gene, a multistakeholder collaboration to incorporate Quality by Design (QbD) principles into a manufacturing case study of a viral vector commonly used in gene therapies.
This presentation provides an overview of the investment, clinical, and scientific environment for cell and gene therapy, including major milestones from 2021 and a look ahead at what 2022 has in store.
ARM’s annual State of the Industry briefing provides an update on global financings, clinical development, public policy considerations, and other regenerative medicine sector trends. A recording of the presentation is available here.