ABSTRACT

The research organization is a critical determinant in the economic success of most companies. Successful development of new biological products depends upon integration of the research organization at all levels in the company. The aim of process development is quantitative delineation of all key factors which will permit timely and economic design and construction of an operating plant which will then perform in a stable, predictable, and cost-effective manner to produce a desired product of known quality at a determined rate. The drawings should encompass “as built” construction, plot plans, process and instrumentation drawings, isometrics, undergound lines and all schematics. The selection criteria involve the microbe and its metabolism, of course, but other factors are cost, availability, ease of handling, storage requirements, downstream processing, and waste disposal considerations.