Albany Molecular Research, Inc. (AMRI) has announced expanded access to its solutions platform, spanning R&D to manufacturing for orphan and rare disease products. The company has made investments to expand its scale and compound handling capabilities as well as making additions to the teams at its facilities in New York, Wisconsin and Scotland.
The expansion includes additional suites in New York, designed to manufacture batch sizes of 10-15 kilograms for the production of rare-disease therapies. The Wisconsin facility has expanded its hydrogenation, filtering and drying and analytical capabilities. It has added liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry instruments in expanded laboratory space, and recruited additional analytical experts.
Compact filling technologies, coupled with a bracketed media fill approach and single-use philosophy, are employed to help minimise process losses at the Scotland site.
Rare diseases are conditions that affect a limited population, defined in the United States as fewer than 200,000 people and in the European Union as fewer than one in 2,000 people. The need for an integrated, accelerated and agile pathway is acute to speed potential treatments to patients.
In 2020, 31 of the 53 (58%) novel drug approvals by FDA’s Center for Drug Evaluation and Research were approved to treat rare or orphan diseases. Evaluate Pharma anticipates a 12% compound annual growth rate in prescription sales of orphan drugs from 2020 through 2026.
“AMRI is committed to making a difference for the innovators that meet the challenges of orphan drugs and, in turn, for the patients living with rare diseases,” said John Ratliff, CEO, AMRI. “AMRI’s scientists and operators dedicate both hearts and minds to these programs, including our regulatory and intellectual property professionals who work closely alongside customers to navigate the complex landscape associated with orphan designations and our scientists who can manage the complexity of these innovative products. Our teams deliver seamless programs for orphan products from R&D through manufacturing with a passionate commitment to ‘right first time’ throughout.”