ABL to perform process development and cGMP manufacturing of recombinant scuPA

Jun 14 2012

Advanced BioScience Laboratories, Inc. (ABL) will perform process development and cGMP manufacturing of recombinant scuPA, an enzyme therapy candidate for patients with pleural loculation or scarring surrounding the lung. scuPA reverses a defect in clot clearance that characterizes pleural loculation. The program is led by Dr. Steven Idell of The University of Texas Health Science Center at Tyler. ABL will develop the production cell line and manufacturing process followed by scale-up and manufacture of toxicology and cGMP clinical materials. The materials produced at ABL will be used to support an IND, and will be used in clinical trial testing.    

This project is being funded in whole with federal support from the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH) in the Department of Health and Human Services (DHHS), under the Science Moving TowArds Research Translation and Therapy (SMARTT) program (Contract No. HHSN268201100014C). ABL is the biologics production facility for the five-year SMARTT program. The program is designed to fill product development gaps to propel clinic-ready products. SMARTT consists of the biologics production facility at ABL, a production facility for non-biologics and small molecules, a pharmacology/toxicology center, and a coordinating center.

Dr. Thomas VanCott, ABL's President and Chief Executive Officer stated, "ABL is privileged to be working with Dr. Idell and The University of Texas Health Science Center at Tyler in support of the scuPA program. This is an exciting product with the potential to prevent numerous surgeries with associated serious morbidity."

Dr. Idell said, "This is an exciting project that is the culmination of twelve years of bench science now being developed as a novel therapeutic agent. We are most pleased to be working with our expert partners at ABL to move this new NIH SMARTT project forward, and hope it will be a key step that will introduce new and better therapy for pleural loculation into clinical practice."