HPAPIs : From niche capability to core competency
Daniele Vigo , assistant director of R & D and process development , and Matt Bio , chief scientific officer , at Cambrex , share a case study from the company ' s new process development lab .
Advances in pharmaceutical sciences and drug discovery have resulted in the development of new drugs that are effective at very low doses , collectively referred to as highly potent APIs ( HPAPIs ). These are mostly used in oncology but are increasingly being developed in a broad range of therapeutic areas , such as asthma and pain management .
HPAPIs are typically defined as having an occupational exposure limit ( OEL ) of ≤10 µ g / m 3 . The US National Institute for Occupational Safety & Health ( NIOSH ) has developed an occupational exposure banding ( OEB ) methodology to assign compounds into specific subcategories based on OEL levels . 1
During drug development and manufacturing , HPAPIs require the application of stringent procedural controls , along with advanced engineering controls to enable the safe production , handling , containment and disposal of the active compounds , in order to minimise the risk of worker exposure by inhalation , skin adsorption or ingestion .
Figure 1 - Configuration of processing isolator at Milan site
28 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981