Alphora has completed a GMP Kilo lab for the scale-up of high potency/cytoctoxic compounds with occupational exposure limits (OELs) of 10μg/m3 or less. The expansion is part of the company’s 2011 capital program, which included a separate R&D suite with isolator containment, along with additions to headcount, R&D, analytical services and warehousing.
The kilo lab is designed to handle Class 4 high potency active pharmaceutical ingredients (HPAPIs) and is equipped with glove-box technology for operating and isolating reactions to the 50L scale. The facility employs pressure lock entryways and dedicated HEPA filtered air-handling systems suitable for class 100,000 use.
Alphora Research operates FDA inspected and approved operations that total 45,000 sq. ft., and include synthetic laboratories, analytical laboratories, GMP kilo laboratories, GMP pilot plant, GMP stability studies and supporting QC/QA.