The biopharma industry has increasingly moved toward more potent and selective active pharmaceutical ingredients and, while this has had great therapeutic advantage, it can pose risks to those employees who manufacture these highly potent active pharmaceutical ingredients (HPAPIs) and final drug products. It can also be challenging for drug developers to locate contract manufacturing services that are able to manage the very low occupational exposure levels (OELs) associated with these unique products. This is particularly challenging when developing and manufacturing highly potent injectable and infused biologics. The crossroads of current good manufacturing practices (cGMPs) and low OELs can involve some of the most complex engineering, product quality, and industrial hygiene challenges found within in the pharma industry.
Tom Evans is the director of Safety, Health, and Environment (SHE) at Ajinomoto Bio-Pharma Services (Aji Bio-Pharma), which recently commissioned a new high potent aseptic vial filling line. His team’s role in this project, along with Karl Kasai at Kasai Consulting, is to ensure Aji Bio-Pharma can effectively produce a client’s drug using HPAPI without risk of exposure to facility personnel, a critical factor in successfully bringing many of today’s novel highly potent drugs to market. In this Q&A, he discusses the resources and capabilities necessary to do so.