Advanced BioScience Laboratories to provide Cell Line Development, Process Development, and cGMP Manufacturing …

ROCKVILLE, Md.--(BUSINESS WIRE)--

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, ABLs 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.

About The University of Texas Health Science Center at Tyler (UTHSCT)

UTHSCT is one of six University of Texas health institutions. The institution is nationally recognized for its scientific programs in lung injury research, infectious lung diseases and comprehensive clinical programs in chest diseases, environmental medicine, and cancer. Educational highlights at UTHSCT include popular family medicine, internal medicine, and occupational medicine residency training programs and a new masters program in biotechnology has been initiated. A number of investigators partnered with Dr. Idell at The Texas Lung Injury Institute to move the scuPA project forward, including Dr. Idells collaborators on his $8 million Program Project Grant from the NIH. New therapeutics for pleural disease are being developed by Dr. Idell, Dr. Andrey Komissarov, and colleagues on an ongoing NIH CADET grant from the NHLBI.

About the NHLBI

The NHLBI stimulates basic discoveries about the causes of disease, enables the translation of basic discoveries into clinical practice, fosters training and mentoring of emerging scientists and physicians, and communicates research advances to the public. It creates and supports a robust, collaborative research infrastructure in partnership with private and public organizations, including academic institutions, industry, and other government agencies. The Institute collaborates with patients, families, health care professionals, scientists, professional societies, patient advocacy groups, community organizations, and the media to promote the application of research results and leverage resources to address public health needs. The NHLBI also collaborates with international organizations to help reduce the burden of heart, lung, and blood diseases worldwide.

Information for the SMARTT program is also available on the NHLBI website at http://www.nhlbi.nih.gov/new/SMARTT.htm.

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Advanced BioScience Laboratories to provide Cell Line Development, Process Development, and cGMP Manufacturing ...