Take Process Improvement Step-by-Step

According to a special March 2008 issue on bioprocess design, by BioProcess International, biopharmaceutical manufacturing involves four principle operations. Each operation consists of a separate series of manufacturing steps called Unit Processing Operations (UPOs).

The four principle operations are:

• Cell culture (otherwise known as the fermentation)
• Clarification
• Purification (purification of proteins, pharmaceuticals etc.)
• Fill-finish

Each UPO has it's own set of product quality attributes to aim for, and operating parameters for achieving those goals. Breaking down the manufacturing process into these four steps, and focusing on the separate quality attributes of each, is one approach to simplifying the process and assessing where PAT and other quality assurance mechanisms can be put into place.

_Source:

BioProcess International, March 2008.