Michael Avraam at ChargePoint Technology walks IPT through the challenges and obstacles that companies face when looking to build safety, quality, and efficiency into their potent active pharmaceutical ingredient API processes. In manufacturing, why are these APIs more challenging, expensive, and risky to produce? Michael Avraam: APIs vary in potency depending on their level of concentration, and the huge variations in what can be classified as a highly potent or a traditional API poses challenges when it comes to understanding their individual handling requirements.
This enhances the efficacy of the finished drug and allows for smaller dosage sizing, potentially reducing the incidence and severity of adverse side effects in patients.
Steps must be taken to safeguard line operatives against exposure, or to ensure containment of waste products to prevent potent chemicals entering the environment surrounding the site to jeopardise wildlife or local communities. Not only must appropriate measures be put in place to ensure adequate containment of these chemicals, but they must also be tailored to the specific nature of the material being processed. Failure to do so can have significant legal and financial repercussions for drug developers.
They could be fined if they are found guilty of failing health and safety or environmental standards, and could suffer long-term reputational damage as well. This could impact on future revenue and business growth, or even affect recruitment and staff retention. A growing number of new chemical entities NCEs entering the drug development pipeline are classified as HPAPIs, making it all the more important to take steps to safeguard employees from exposure to comply with legislative requirements.
Before developers can begin handling an HPAPI, they must first evaluate and classify its occupational exposure band, or occupational hazard class OHC , to define the required containment and handling controls. The required measures vary depending on the level of exposure hazard, but fundamentally, all stages of handling HPAPIs must be carried out in a contained environment.
