Understanding GLP and cGMP regulatory framework for cell-based products to support early-phase clinical trials

The development of cell-based products is a growing field which is receiving a great deal of attention due to the potential of regenerative medicine. When developing new cellular products for clinical trials, it is important to understand the regulatory guidelines that must be followed to ensure that translation from bench to bedside is in accordance with regulations. The path for bringing a new cell-based drug to market in the USA usually falls under the IND pathway laid out by the US Food and Drug Administration, and generally requires preliminary nonclinical studies performed according to GLP guidelines followed by clinical trials and an eventual license application. Additionally, the manufacturing of these products must follow relevant cGMP guidelines. In this work, we summarize relevant GLP guidelines for nonclinical studies and outline cGMP manufacturing requirements needed to bring cell-based INDs to a Phase 1 clinical trial.

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