ROCKVILLE, Md.--(BUSINESS WIRE)--ABL, Inc. (ABL), a global contract research and manufacturing organization to the U.S. Government and biopharmaceutical industry, is pleased to announce the award of contract #HHSN271201700010I from the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH), to provide “Contract Research Organization support for drug substance development and manufacture.” The contract is an Indefinite Delivery Indefinite Quantity contract task order-based contract.
ABL will provide the Division of Pre-Clinical Innovation (DPI) at NCATS with a wide range of development and chemistry, manufacturing and control support services to advance promising therapeutics into clinical testing. This support will utilize ABL’s in-house translational research and Good Manufacturing Practice (GMP) capabilities for biologic protein and virus vector product development. Product types that may be developed under the program include recombinant proteins, monoclonal antibodies, gene therapies, vaccines, plasmids, small molecules and cellular therapeutics.
ABL has partnered with NIH product development teams on several multidisciplinary manufacturing contracts, resulting in over 100 manufacturing task orders targeting process development and GMP production of early phase candidates. ABL teams are tightly integrated across all aspects of product development to efficiently advance new concepts in therapeutic design into the clinic through structured planning, feasibility, risk mitigation and execution.
“We are pleased to be awarded this product development contract in support of NCATS scientists’ efforts to accelerate therapeutics into the clinic. ABL has a comprehensive array of translational research and GMP resources to support DPI drug development programs,” stated Dr. Thomas VanCott, ABL’s President and CEO.
Ms. Beth Tebeau, Vice President of ABL Manufacturing said, “We have a wealth of experience working on therapeutic development projects, using diverse platforms at various stages of development. ABL is well adept in addressing the complex technical issues often encountered in biological drug development and meeting the highest industry and regulatory standards."
ABL, Inc. is a global biomedical contract research and manufacturing organization dedicated to advancing therapeutics, vaccines and other biologic products. ABL maintains U.S. and European immunological and molecular laboratories to support preclinical and GCLP clinical sample processing and testing. Additionally, 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 is a part of the Institut Mérieux, a group of companies dedicated to developing translational science for better patient care globally.