Validation of Biotechnological Synthesis

The suggested tolerances for the validation parameters in the FDA recommendations for bioanalytical methods [16] are rather wide, with C.V. values 15%. For pharmaceutical product analysis the requirements are tighter with C.V. values 2% [82], This is possible, since in the latter case the matrix is typically much simpler and the analyte concentration can be chosen freely, so that extremely low/high concentrations can be avoided. 

There are no detailed recommendations for analytical procedures in the field of biotechnological production of drugs, in contrast to the recommendations made by the FDA for bioanalytical methods [16], The absence of detailed guidelines for analytical method validation in this field is surprising. It is important to validate the quantification of both substrate and product during the process, at definite time intervals, to ensure proper calculation of the kinetics of the process i.e., the coefficients of substrate conversion, and production rates must be adequately calculated. The aim of the study in pa- 

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II. Guidelines for analytical method development and validation of biotechnological synthesis of drugs. Production of a chiral steroid as model. 

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