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."
Source:
Advanced BioScience Laboratories, Inc.
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