AMRI Adds R&D and Mfg. Solutions for Orphan Products

Albany Molecular Research, Inc. (AMRI), a global provider of contract research, development and manufacturing services, expanded access to its accelerated solutions platform, spanning R&D to manufacturing for orphan and rare disease products. The company made targeted investments globally to expand its scale and compound handling capabilities and made additions to the teams that address the specific needs of these complex products in its facilities in Albany, NY, Grafton, WI, and Glasgow, Scotland.

The expansion includes addiational GMP suites in Albany 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 and added liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry instruments, and recruited additional analytical experts. 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.

“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.”