Albany Molecular Research, Inc. (AMRI)
Albany Molecular Research, Inc. (AMRI), a leading global provider of advanced contract research, development and manufacturing solutions, today announced expanded access to its accelerated solutions platform, spanning research & development to manufacturing for orphan and rare disease products. The company has made targeted investments globally to expand its scale and compound handling capabilities as well as made additions to the expert teams that address the specific needs of these complex products in its facilities in Albany, New York; Grafton, Wisconsin and Glasgow, Scotland.
The expansion includes additional suites in Albany that meet Good Manufacturing Practice (GMP) requirements which are designed to manufacture batch sizes of 10-15 kilograms, which is critical for the production of rare-disease therapies. AMRI’s Grafton 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 who assure products meet the intended specifications. AMRI’s Glasgow facility is an integrated single site with formulation development and clinical sterile drug product manufacture capabilities, which supports formulation and process development and GMP manufacture of orphan drug products.
Compact filling technologies coupled with a bracketed media fill approach and single-use philosophy help minimize process losses at the site to enable efficient and robust delivery for low-volume, high-value products.
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 products used to treat rare diseases are complex and innovative, addressing unmet needs using high-value drug substance. The need for an integrated, accelerated and agile pathway is acute to speed potential treatments to patients.
“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.”
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 diseases1. Evaluate Pharma anticipates a 12% compound annual growth rate in prescription sales of orphan drugs from 2020 through 2026. AMRI’s specialized solutions for rare and orphan drugs leverage deep expertise in sterile injectable formulation and development; flexible scale with grams to kilograms within one facility to minimize timeframe and technical transfers from site to site; expert regulatory services for faster and accurate filings; and intellectual property consulting to enhance product strategy. This expertise and scale enables swift progression from laboratory to cleanroom while mitigating scale-up risk.