|
|
|
|
| As the patient’s immune cells are the starting materials, inherent biological variability leads to CAR-T manufacturing. Additional critical raw materials also have batch-to-batch variability, which means the entire production process is a constant balancing act of adjusting the manufacturing process to create standardized manufacturing. Join Cell & Gene Live for a discussion on practical ways to overcome the challenges associated with batch-to-batch variation. Registration is free thanks to the support of Entegris. |
|
|
|
|
By Tim Sandle, Ph.D. | The FDA recently released a draft guidance, Potency Assurance for Cellular and Gene Therapy Products. This article summarizes the draft guidance. The public comment period ends March 27, 2024. |
|
|
|
Cell & Gene Live | In this segment, Dr. Peter Marks shares developments in CMC for advanced therapies in the near future. |
|
|
|
|
|
| Adopting Modular, Semi-Automated Approaches | Article | By Rubina Pal and Alicia Kramer, Comprehensive Cell Solutions, A Business Unit of NYBC Enterprises | Unearth several technology solutions that, when applied to a cell and gene therapy workflow, have the potential to streamline development and improve workflow integration. |
|
|
|
| Accelerating AAV Analytical Development And Testing | Article | By David Colter, Ph.D., and Dan Stringer, Ph.D., The Center for Breakthrough Medicines | Finding a CDMO that can perform all the necessary testing for an AAV product can make a significant difference for a nascent company or novel drug. |
|
|
|
|
|
|
| Connect With Cell & Gene: |
|
|
|
