GenScript USA has expanded its global current Good Manufacturing Practices (cGMP) single-guide RNA (sgRNA) manufacturing capabilities to meet the growing demand for cell and gene therapies.
The 400,000 square-foot cGMP facility enables gene and cell therapy R&D programmes to advance IND filings and clinical trials. The company’s new Zhenjiang, China cGMP facility is scheduled to open in 2023.
“We are pleased to partner with these prestigious biotechnology companies in advancing cell therapies for the betterment of those that are sick and in need,” said Michael, Head of GMP Business Development at GenScript. “Our goal is to provide, with the fastest turnaround time, high-quality reagents that conform to the regulatory requirements necessary to support regulatory filings, clinical trials, and commercialisation of these very important drug therapies.”
One such partner is Shanghai BRL Medicine, which was recently granted an investigational new drug (IND) application for its BRL-201 in relapsed/refractory B-cell non-Hodgkin’s lymphoma by the China Center for Drug Evaluation, National Medical Products Administration.
BRL-201 was developed using Quikin CART, BRL’s non-viral site-specific integration platform, which can produce CAR-T cell products using one-step, non-viral preparation.
BRL Medicine was granted IND clearance from the CDE for its first gene therapy product, BRL-101, for transfusion-dependent β-thalassemia, earlier this year.
Nanjing BioHeng Biotech also received CDE approval in March 2022 for its universal UCAR-T drug, CTA101, which targets CD19 and CD22 for the indication of adult recurrent or refractory B-cell acute lymphoblastic leukaemia.