Albany Molecular Research (AMRI), a contract research and manufacturing organization that provides drug discovery, development, cGMP manufacturing and aseptic fill and finish to the pharmaceutical and biotechnology industries, recently announced it has been granted a 10-year federal contract award care of the National Institutes of Health (NIH) to secure their drug development and manufacturing services. Under this agreement, the NIH/National Institute of Neurological Disorders and Stroke (NINDS) award will fund the NIH’s Drug Manufacturing and Formulation Program (DMFP), under the Blueprint Neurotherapeutics Network (BPN).
AMRI’s new award continues years of support from the NIH BPN, which started in 2011, and has since then provided the network with chemistry and discovery technologies. AMRI’s collaboration with the NINDS, however, began back in 2005, wherein the Company was contracted to provide medicinal chemistry services on new treatments for spinal muscular atrophy, a degenerative neuromuscular disease.
“AMRI was selected for this contract award because of our proven track record on projects with NIH and our demonstrated expertise in drug manufacture and formulation, which is enriched by our integrated pharmaceutical services platform,” said AMRI’s President and CEO, William S. Marth. “Since our initial NIH BPN award in 2011, AMRI has provided discovery chemistry services to NINDS and its private sector BPN members on 15 drug candidate programs, and two of these programs have advanced to the stage where a pre-clinical candidate has been declared, with a third candidate pending. This significant award demonstrates the NIH’s continued focus on addressing high unmet clinical needs for patients with inadequate treatment options. We are pleased to support NIH/NINDS’ efforts and provide our end-to-end expertise to the neuroscience research community and to patients who suffer from devastating neurological and degenerative diseases.”
The new contract entitles AMRI to a grant worth $37.3 million, which was derived from the number of approved projects and the NIH’s availability of funds for BPN initiatives that have successfully demonstrated favorable early-stage results from clinical trials. In return, AMRI will be providing the following services: manufacture of active pharmaceutical ingredients (API); drug product formulation; analytical testing; and clinical trial supply chain management, including packaging, labeling, storage, and distribution of the completed drug product.
Under the DMFP, AMRI will be tasked to complete manufacturing, documentation, formulation, fill and finish, packaging, and labeling required for BPN compounds. AMRI will leverage its integrated service offering for formulation development, analytical services and API manufacturing, and distribution of the completed drug product.
The DMFP’s main mission is to provide support to the NINDS and BPN contributors, which are affiliated drug companies and key academic investigators, and be a reliable source of comprehensive support services for the development and manufacturing dosage forms of small molecule pipeline drugs, appropriate for use in preclinical and clinical testing of neurological disorders.