CELL AND GENE THERAPY | Pharmaron
J O U R N A L
Developing Meaningful Assays: Balancing Biological Significance and QC-Compatibility - Oxford Global
MONTHLY UPDATE - MARCH 2015
Addressing potency-assay related development delays for cell and gene therapies - Alliance for Regenerative Medicine
Potency assay development for cellular therapy products: an ISCT∗ review of the requirements and experiences in the industry - Cytotherapy
E-BOOK: Potency Assay Guide, 3rd Edition | Pharmaron
Building a Robuts Bioassay for Product PotencyBioProcess International
Potency assays for ATMPs: overcoming challenges on the path to commercialization - Insights From Our Labs to Yours
Biological Assay Development, Validation & Maintenance
Potency assay development for cellular therapy products: an ISCT∗ review of the requirements and experiences in the industry - Cytotherapy
Critical considerations for the development of potency tests for therapeutic applications of mesenchymal stromal cell-derived small extracellular vesicles - Cytotherapy
What you should know about potency assays - Biopharma Excellence
POTENCY ASSAYS for CELL THERAPY PRODUCTS
.png.aspx "Public Meeting with FDA Oct. 19 Will Focus on Potency Assays for CGTs | ASGCT - American Society of Gene & Cell Therapy")
Public Meeting with FDA Oct. 19 Will Focus on Potency Assays for CGTs | ASGCT - American Society of Gene & Cell Therapy
Development of an In Vitro Biopotency Assay for an AAV8 Hemophilia B Gene Therapy Vector Suitable for Clinical Product Release - ScienceDirect
Frontiers | A Regulatory Risk-Based Approach to ATMP/CGT Development: Integrating Scientific Challenges With Current Regulatory Expectations
Drug Lot Release Potency Assay / Testing - Marin Biologic Laboratories
PPT - Potency Measurements for Cellular and Gene Therapy Products PowerPoint Presentation - ID:247170
Cell-Based Potency Assay Development - BioProcess InternationalBioProcess International
An ex vivo potency assay to assess active drug levels of a GLP-1 agonistic peptide during preclinical safety studies | Bioanalysis
Adam Feuerstein on Twitter: "Unsure if this is new information, but $PFE has not enrolled US patients into its Duchenne gene therapy ph3 study due to unresolved FDA issues w/ potency assay.
Mesoblast's 2nd attempt for cell therapy approval moves ahead
The Essential Need for a Validated Potency Assay for Cell-Based Therapies in Cardiac Regenerative and Reparative Medicine. A Practical Approach to Test Development | SpringerLink
