The continued development of the biopharmaceutical industry has resulted in a significant increase in demand for manufacturing capacity. The construction of a biopharmaceutical manufacturing facility is a major undertaking, even for large, established pharmaceutical companies. Wyeth's Grange Castle facility in Dublin, Ireland, is an example of a modern integrated biopharmaceutical campus. For smaller start-up companies, the risk level and levels of human and financial capital investment required to build a manufacturing facility can be prohibitive. A large biopharmaceutical plant with the ability to generate bulk drug substance and manufacture final drug product can take up to 5 years to build and can cost up to $1 billion. Due to timeline considerations, the construction of these expensive facilities is often underway before the efficacy of the medicine or the marketplace demand is known. Because of the inherent risk and high cost associated with building a manufacturing facility, many companies decide to partner with another company with existing capacity or use a contract manufacturer.
There is a complex interplay between facility design, process development, and market assessment. It is not unusual for market volume predictions to vary by 50-100 % or more during the development of an innovative newbiopharmaceutical. For new facilities, where emerging market data exceed the initial design capacity, a difficult series of decisions must be made. A change to the facility design during the detailed planning phase will usually incur cost and time penalties. A similar change once construction has commenced can involve maj or increases in project cost and timelines. In this environment, the value of an effective process development unit and a sophisticated approach to project management are invaluable. An innovative process development group can help mitigate extra expense by increasing process output or recovery, in the bioreactor or downstream process respectively, increasing plant output without additional capital spending.
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