From sugar beet molasses to Lyphan. Integrated quality management from the raw material to the drug

L-tryptophan is produced at the AMINO GmbH (Frellstedt, FRG) via biocatalytical condensation of the amino acid L-serine with indole. As a biocatalyst, tryptophan synthetase is used which is produced in high activities by a natural mutant Escherichia coli strain. The enzyme mechanism and specificity and the individual process-parameters for the biotransformation procedure are explained as well as the purification process of educts and products. This includes a detailed description of the quality control of educts, intermediates and final product. The active ingredient L-tryptophan is subsequently used by AMINO's subsidiary company esparma GmbH to produce and distribute the pharmaceutical Lyphan. The quality management system and the production procedure for Lyphan are described and discussed.