In this webinar, Tom Evans, MS, CMMS, an expert in hazardous manufacturing controls, discusses the planning, resources, and capabilities necessary to effectively produce a client’s highly potent active pharmaceutical ingredient (HPAPI) therapeutic, while effectively controlling the risk of exposure to operating personnel. Controlling exposure is a critical factor in successfully bringing many of today’s novel, highly potent drugs to the clinic and eventually to the commercial market. Successful manufacture of HPAPIs includes containment design and installation considerations, Best Industrial Hygiene Practices, Good Manufacturing Practices, and the process of characterizing, challenging, and verifying isolator performance.
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 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 (OEL) associated with these unique products. This is a particularly challenging dilemma when developing and manufacturing highly potent injectable and infused biologics. The crossroads of current Good Manufacturing Practices (cGMP) and low OELs can be some of the most complex engineering, product quality, and industrial hygiene challenges found within in the pharma industry. Developing containment strategies that allow employees to work with these therapeutics in a production environment and effectively control the risk of exposing them to occupational illness must be a sustained business focus.
Overall, there is a considerable amount of work and expertise necessary to ensure employee exposure to toxic materials in a facility manufacturing HPAPIs is below the acceptable limits. As biomanufacturers venture into the rapidly growing market of HPAPIs, it is important to consider whether they have the resources and capabilities to protect their product and their employees. The lack thereof can threaten not just the ability to provide a safe working environment for production workers but also the ability to bring these important therapeutics to the patients that need them.