How to take a safety-first approach when harnessing the power of HPAPIs
Michael Avraam , director of applications and solutions engineering at ChargePoint Technology , explores the challenges of handling high potency APIs safely and discusses how to comply with regulations
The global high potency API ( HPAPI ) market is undergoing rapid growth , forecast to reach nearly $ 27.9 billion by 2027 , growing at a CAGR of 6.1 %. 1 This surge has largely been driven both by the potential of HPAPIs as sources of exciting new treatments for serious or chronic diseases , and their unique patient convenience benefits . HPAPIs elicit a more targeted pharmacological effect in lower concentrations compared to traditional APIs , reducing the dosage size and minimising potential side effects for patients . In addition , they are able to receive fast-track designation or accelerated approval from the US FDA . This is done to facilitate the development and expedite their review to fill the unmet needs of patients with serious , life-threatening conditions . Ultimately , this helps get life-changing drugs to patients at a faster rate than traditional drug products . However , when it comes to handling HPAPIs , there are many challenges to ensuring safe development and manufacturing processes . Pharmaceutical companies must carefully consider the design of their production lines and implement standard operating procedures ( SOPs ) to minimise the potential for line operatives to come into contact with the materials .