ABL, Inc. Announces Agreements with REGENXBIO for Process Development, Scale-Up and Clinical Manufacturing of RGX-501
May 24, 2016 (Rockville, MD) – ABL, Inc. (ABL), a global contract research and manufacturing organization to the biopharmaceutical industry, today announced agreements with REGENXBIO, Inc., a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its proprietary NAV® Technology Platform, to manufacture its lead product, RGX-501, for human clinical trials. RGX-501 is a novel therapeutic for the treatment of homozygous familial hypercholesterolemia (HoFH), which uses the NAV rAAV8 vector to deliver the human low-density lipoprotein receptor (LDLR) gene to liver cells.
Under the agreements, ABL will continue process development work and initiate the transfer and scale-up of the RGX-501 manufacturing process at its Rockville, MD cGMP production facility. The site is designed as a multi-product facility utilizing single-use, disposable technologies for the development and production of gene therapies, vaccines, protein immunotherapeutics, and other biologics-based products for use in human clinical trials.
“We are delighted to be supporting REGENXBIO and the RGX-501 program,” said Thomas VanCott, Ph.D., President and CEO of ABL, Inc. “AAV-based vectors have demonstrated remarkable promise in addressing some of the most challenging human diseases, and REGENXBIO is at the forefront of applying the next generation of AAV vectors through its NAV Technology Platform. ABL has an established track record of cGMP virus vector manufacturing, and we are very excited to be applying our bulk production and fill/finish expertise to the RGX-501 program.”
ABL, Inc. is a global biomedical contract research and manufacturing organization dedicated to advancing therapeutics, vaccines and other biologic products. ABL has extensive experience working with diverse organizations, including industry, government and academic entities. With GMP facilities meeting U.S. and European regulatory standards, ABL’s manufacturing services include process and assay development, cGMP biologics manufacturing of bulk drug substance, cGMP aseptic fill and finish of drug product, and QC analytics. ABL also maintains U.S. and European immunological and molecular laboratories to support preclinical and GCLP clinical sample processing and testing. ABL is a part of the Institut Mérieux, a group of companies dedicated to developing translational science for better patient care globally.