Alphora has completed a cytotoxics R&D lab, as part of an on-going $4 million capital program for 2011. The program also includes additions to R&D, GMP operations, analytical services and staffing.
The R&D lab is designed to handle high potency active pharmaceutical ingredients (HPAPIs) and class four compounds. It’s equipped with three hard enclosure isolator units, pressure lock entryways and dedicated class HEPA filtered air handling systems.
Alphora’s R&D has been expanded by 50% with the installation of additional fume hoods for process chemistry development and a GC/MS instrument for further API characterization and control of Genotoxic Impurities (GTIs), and increasing the overall company headcount to 95 employees. Other expansion plans include constructing a fourth cGMP Kilo Lab, adding a 10,000-sq.-ft. GMP warehouse, and installing a new Enterprise Resource Planning (ERP) system, which are expected to be complete in 4Q11.