Standard Methods for Quality Control in Cell-Based Medicinal Products and their Validation for Clinical Applications. [PDF]
Mahmoodi Khaledi E +7 more
europepmc +1 more source
Trends in EU regulatory assessment of oncology medicines. [PDF]
Pabsch T +4 more
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Designs of the clinical trials aiming at evaluating cell and gene therapy products: A critical appraisal from a literature review. [PDF]
Biard L +3 more
europepmc +1 more source
Securing raw materials, reagents, and consumable supplies in the academic bioproduction UNITC network: because the chain is only as strong as its weakest link. [PDF]
Chartral U +34 more
europepmc +1 more source
Vulnerability, protection and fairness: ethical and regulatory limits in small-N gene therapy trials. [PDF]
Reckelbus M +3 more
europepmc +1 more source
Reimbursement routes and past practices for advanced therapy medicinal products in the Netherlands. [PDF]
Gort J +6 more
europepmc +1 more source
Clarifying the critical differences between the enzymatic stromal vascular fraction and the mechanically derived stromal vascular tissue or nanofat for spinal cord injury applications. [PDF]
Nonnarath C, Serratrice N.
europepmc +1 more source
Pathing the way from regulatory approval to market access for gene therapy products (GTPs): An integrative review in the US, EU5, Japan and China. [PDF]
Shi J, Hu H, Ung COL.
europepmc +1 more source
Developing and validating a regulatory science competency framework for immune cell therapy: a mixed-methods study. [PDF]
Lee JA.
europepmc +1 more source

