PUBLISHED ON:JANUARY 4, 2021
CATEGORY:DEVELOPMENT AND MANUFACTURING
Application & Manufacturing of High Potent Active Pharmaceutical Ingredient (HPAPI)
High Potent Active Pharmaceutical Ingredient (HPAPIs) are majorly used to treat oncology-related conditions. Usually, a compound is considered high-potent when the operational exposure limit is below 10 µg/m3 of air as an 8-hour time-weighted average. High Potent drugs can be administrated through oral, injection or topical route depending on the source of the disease. The majority of the HPAPIs are small molecules with a known therapeutic property and the absorption rate is high.

The manufacturing of high-potent active pharmaceutical ingredient (HPAPI) requires stringent safety conditions and containment. Because of the high investment in infrastructure and capabilities, many pharma companies outsource their high potent API needs to Contract Research and Development Organizations (CDMOs). CDMOs such as Aurigene Pharmaceutical Services, are well equipped to support. A usual outsourcing project starts with a chemical entity test to define the occupational exposure limit (OEL). Once the OEL is established, the containment plan is devised to assess the buffer between no effect and effect. This buffer helps in preventing human exposure and avoiding contamination.