API Manufacture

Processes are performed under controlled conditions in order to maximise the yield of the the Active Pharmaceutical Ingredient (API). Chemical reactions are the traditional method for API production. New API's are increasingly using biotechnology.

Process can be open or closed processes. Open processes tend to use less complex technology, but are more dependant upon the local environmental conditions and operator training.

Upstream Activities

This process covers all areas which accommodate process steps that handle live organisms. An inoculum is prepared from genetically engineered cells, in scale-up steps, until enough inoculum is made to aseptically inoculate the final, sterile media-filled bioreactors. The API is then produced by aerobic or anaerobic fermentation in these bioreactors.

Although the demarcation between upstream and downstream varies with specific processes, upstream activities typically end with a recovery harvesting step in order to separate the cells from the media. Media preparation facilities provide support to these areas. Although media preparation does not involve cell processing, it is traditionally considered an upstream activity.

Downstream Activities

The API is isolated and purified at this stage. This API may be located either in the cells or the media. Separation techniques are employed such as centrifugation, filtration, crystallisation, chromatography and drying. The purified API is collected and sealed in a container under a controlled environment. Buffer preparation and staging, activities in direct support of purification, are traditionally considered downstream activities.

PEC (Denmark) A/S - Telephone +45 23 32 43 78 - Mail info@pec.dk
© PEC all rights reserved