ABL Awarded $Multimillion Contract to Provide Manufacturing and Nonclinical Services to Support Development of Promising Therapeutics for the NINDS
04 Nov 2022
Gene TherapyVaccine
ROCKVILLE, Md., Nov. 4, 2022 /PRNewswire/ -- Advanced BioScience Laboratories (ABL), a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) to the U.S. Government and biopharmaceutical industry, announced it is one of three contractors awarded an Indefinite Delivery, Indefinite Quantity (IDIQ) contract for "Manufacturing and Nonclinical Studies support for Development of Therapeutic Biotechnology Products (Biologics) for Neurological-related Disorders" by the National Institute of Neurological Disorders and StrokeNeurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH) of the U.S. Department of Health and Human Services (HHS), contract number 75N95022D00023.
ABL & NINDS Partnership
The eight-year, multiple-award-IDIQ contract has a total potential funding value of $149.2M million. ABL, as an awardee of the IDIQ contract pool will provide NINDS current Good Manufacturing Practices (cGMP) manufacturing and Good Laboratory Practice (GLP) nonclinical (preclinical) services to support translational development of therapeutic biotechnology (biologics) products of various modalities for NIH's drug discovery and development programs. This contract supports the NIH Biologics development projects for the NIH Blueprint Neurotherapeutics Network Biologics (BPN-Biologics) program, the NINDS Ultra-Rare Gene Therapy (URGenT) program, the Helping to End Addiction Long-term Pain Therapeutics Development Program (HEAL-PTDP), and other extramural or intramural NIH drug discovery and development programs. ABL's portfolio of services includes feasibility studies, process and assay development, cGMP manufacturing, IND-enabling GLP safety, pharmacokinetic and efficacy studies, stability studies, and product release testing. These services are provided either at ABL facilities or at one of the 42 companies that formed the ABL Collaboratory to support this contract.
ABL's scientists have been supporting NIH's mission since the 1980s. Our Government Solutions staff has worked hand-in-hand with government and industry key opinion leaders (KOLs) for many years to develop novel biomedical products.
"We look forward to continuing to serve the mission of the NIH through this contract with NINDS and in support of the most innovative investigators in the field who are developing cutting-edge products that prevent, treat, and cure neurological disorders, stroke, and ultra-rare genetic disease," said Marykay Marchigiani, COO of ABL.
About ABL
ABL, Inc. is a global contract research and manufacturing organization dedicated to advancing therapeutics, vaccines and other biological products. ABL has extensive experience working with diverse organizations including industry, government and academic entities. ABL maintains global GMP facilities meeting U.S. and European regulatory standards, providing manufacturing capabilities for the development and production of virus-based oncolytic therapies, gene therapies and viral vaccines. Our services include bulk drug substance, live virus fill/finish, process and assay development. We also support clients' preclinical and clinical sample processing and testing needs through our immunological laboratories. ABL is a part of the Institut Mérieux, a group of companies dedicated to developing translational science for better patient care globally.
www.ablinc.com
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