CIP Systems For Process Development And Clinical Production, Part 1

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•Application Note: CIP Systems For Process Development And Clinical Production

Part one of four

Those who managed to stay awake during history class might recollect the "voyages of discovery" that uncorked a stream of immigration from Europe with the promise of success, but were loaded with peril.

The quest for the discovery of pharmaceutical agents carries with it an analogous risk, with many new drug companies facing a "make it or break it" scenario on the basis of a single drug. If these firms fail to make it out of clinical trials they will flounder on the rocks of failure. Even for companies of much larger size, the time and resources required to develop new drug candidates can bring an unwelcome negative financial impact if the project does not lead to a marketable product.

Some companies mitigate investment risk by building multi purpose pilot plant facilities, or contracting the production of pre-clinical / clinical material to multi-product Contract Manufacturing Organizations (CMO). Such multi-product facilities carry the risk of cross contamination associated with multiple products or product changeovers and evolving scientific processes. Demands placed on pilot plant facilities and contract manufacturers by customers include:

• Highly variable product mix within the facility
• Constant addition of new customers and trial formulations
• Fast track testing schedules

Contract manufacturers face additional demands due to:

• Diverse customer compliance expectations
• Strict contractual commitments, requiring tight financial control

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•Application Note: CIP Systems For Process Development And Clinical Production

SOURCE: Sartorius Stedim Biotech