Cell and gene therapy (CGT) products have the potential to cure intractable diseases, bring hope and meaningful benefit to patients in need, and change the way we approach treating disease. These therapies often target rare diseases and conditions, where patients often have limited treatment options. As the CGT product development cycle presents unique challenges and opportunities, BIO is engaging in regulatory advocacy efforts across the product lifecycle. Here you will find BIO consensus documents describing policy positions on a variety of topics, from nonclinical to manufacturing and clinical phases.
This BIO short consensus document describes points to consider regarding comparability for CGT products and was developed by BIO’s Cell and Gene Therapy Manufacturing, Quality and Distribution Task Force.
This BIO short consensus document describes points to consider regarding potency for CGT products and was developed by BIO’s Cell and Gene Therapy Manufacturing, Quality and Distribution Task Force.
