Process Platforms

In order to reduce time and engineering effort during design and construction of such plants, process platforms are required. Process platforms are well defined sequences of unit operations. They will support present and future progress in biopharmaceutical development and production in order to expedite time-to-market.

Major benefits of process platforms are:

• efficient engineering workflow
• precise cost determination and allocation in early design phases
• investigation of marketable cost (no engineering mobilization)
• late decision for investment
• fast project execution
• possibilities for process optimization
• accelerated and reliable start of production
• security of supply

All process platforms consist of several unit operations as basic steps in a process. In general, processes may have many unit operations to obtain the desired product.

Unit operations are:

• media / buffer preparation
• fermentation
• cell removal / harvest
• pooling / storage
• sterile filtration
• capturing / polishing
• virus inactivation / virus clearance
• ultra filtration / dia filtration
• freeze & thaw

Each unit operation is made of standardized technological modules (e.g. sensors, storage bags, mixing devices, filter, transfer sets, connectors, sampling devices, etc.). Those technological modules should be well defined and not be changed or even newly developed, thus allowing a quick and efficient design and execution of projects.