Are You Protecting Employees During HPAPI Manufacturing?

In this webinar, Tom Evans, MS, CMMS, an expert in hazardous manufacturing controls, will discuss 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.

In order to create the necessary safe environment, there are three main areas of responsibility:

Design & Installation Considerations

• Key steps in preparing an effective user-requirement specification plan in order to install an HPAPI fill line

Best Industrial Hygiene Practices vs. Good Manufacturing Practices 

• Quantifying employee exposure when working with very low OEL compounds
• Maintaining strict ISO 5 production and still isolating product from workers (e.g. positive pressure isolator vs. negative containment).
• Equipment cleaning and preventive maintenance
• Training employees to be subject matter experts regarding HPAPI handling
• Ensuring vials are safe to handle and transfer after the filling operation

Characterizing, Challenging, & Verifying Isolator Performance

• How to create a complete commissioning plan that will give operators and SHE staff the tools and confidence to develop safe and effective operating procedures

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.

Speaker

Tom Evans, MS CHMM, Director of Safety, Health & Environment, Ajinomoto Bio-Pharma Services

Tom Evans is the director of safety, health, and environment (SHE) for Ajinomoto Bio-Pharma Services in San Diego, CA, which recently commissioned a new high potent aseptic vial-filling line. He leads the SHE team to ensure that Aji Bio-Pharma can effectively produce a client’s drug while controlling the risk of exposure to operating personnel. Evans has a Master of Science in Environmental Management from National University and is a Certified Hazardous Material Manager. Tom has over 20 years of SHE experience within the life sciences-biopharma industry.

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