Clinical Vector Core

AddtoAny
Share:

The Raymond G. Perelman Center for Cellular and Molecular Therapeutics has established state-of-the-art Current Good Manufacturing Practices (cGMP) clinical vector manufacturing suites for adeno-associated virus (AAV) and lentiviral (LV) vectors. Directed by a leading expert in preclinical and clinical vector production and characterization, our goal is to help realize the enormous promise of gene transfer therapy to address unmet medical needs.

The Clinical Vector Core manufactures clinical and pre-clinical adeno-associated virus (AAV) vectors of serotypes 1, 2, 5, 6, 8, and 9, and Lentivirus (LV) vectors. Novel or modified serotypes will require development prior to scale-up. Products for clinical use are manufactured in compliance with cGMP for Phase 1 and 2 clinical trials. To support pre-clinical work, including pharmacology and toxicology studies, we offer products manufactured using a GMP-comparable process. Research-grade products for proof-of-principle and bridging studies are also offered, in addition to support for long-term stability and device compatibility studies and investigational new drug (IND) submission.

The Clinical Vector Core is a not-for-profit core that welcomes projects from academia, industry, and government on a first-come, first-serve basis.