In this article, Mike Avraam at ChargePoint Technology explores the challenges of handling HPAPIs safely and discusses how to comply with safety regulations. He explains how the use of next-generation containment technology, including single-use components, can support pharma manufacturers in harnessing the potential of HPAPIs while ensuring the safest possible working environment for employees.
The international high-potency active pharmaceutical ingredient (HPAPI) market is growing rapidly. According to Kenneth Research, it is forecast to be worth $33.15 billion by 2025, up from $16 billion in 2016, more than doubling in size in less than 10 years.
This surge has predominantly been driven by the potential these ingredients have for enhancing the efficacy of new drugs for patients. This is particularly the case for the treatment of serious or chronic conditions, including therapies for cancer, cardiovascular diseases, and diabetes.
Despite the separate categorisation of HPAPIs, all active pharmaceutical ingredients have pharmacological potency and each can be categorised on a scale of potency from low, to moderate, potent and highly potent. HPAPIs elicit a more targeted pharmacological effect at a lower concentration when compared to traditional alternatives.
In addition, for many potential drug product applications, HPAPIs can receive fast track designation or accelerated approval to treat the unmet needs of patients often with serious, life-threatening conditions. This means often they pave the way for an expedited route to market, so patients can enjoy the benefits of new, more effective treatments faster.
However, the potent nature of HPAPIs poses many challenges when it comes to their safe handling during the manufacturing process. Careful consideration needs to be taken in the design of production lines, as well as carrying out reliable testing to ensure containment systems effectively minimise the potential for line operatives to come into contact with the materials.
Commensurate with how potentially hazardous HPAPIs are to work with, regulations and guidance surrounding their handling are growing more robust. Regulators are concerned with ensuring a focus on mitigating cross-contamination and that proper facility design is followed for those involved in multi-product operations.
HPAPIs usually are categorised using an occupational exposure band (OEB) strategy, with compounds placed in bands 3, 4 and 5 requiring a variety of special handling and isolation practices. There must also be careful consideration taken when it comes to understanding and applying the variation of banding criteria from one manufacturer to another.
Limiting handler exposure to these compounds necessitates effective containment technologies. When exposed to higher levels of HPAPIs than what is deemed safe, employees would be at risk of undesired health effects, as the compounds can be carcinogenic, mutagenic, or clastogenic.
Where manufacturing processes involve manual intervention, the process of ensuring an effective containment system within a pharmaceutical environment is especially difficult. Compounding the difficulty of maintaining safety is the necessity for containment solutions to maintain operability and keep the productivity of the employees at normal levels.