Process Development Unit
The Process Development Unit develops fermentation and purification processes and in-process analytical assays designed for cGMP manufacture of well-characterized biologics (i.e., bulk substances) for Phase I/II human trials. This work is conducted with limited resources as compared with industry.
The unit develops scalable fermentation and purification processes using current fermentation, recovery, and chromatographic technologies, as well as analytical techniques for biochemical characterization of bulk drug substances. Fermentation optimization includes analysis of the effects of temperature, pH, and methanol/ethanol feed rates on the production of yeast-derived proteins. The biochemical and biophysical characteristics of recombinant proteins are analyzed by SDS-PAGE; reverse-phase high-performance liquid chromatography (HPLC); analytical size exclusion with an inline, multi-angle light-scattering detector HPLC; mass spectrometry; and amino-terminal sequencing. The impurity profiles for endotoxin and host cell proteins are determined as well.
The Process Development Unit works with the National Institute of Diabetes and Digestive and Kidney Diseases’ Biotechnology Unit, the NIAID Research Technologies Branch, and the Molecular Interactions Resource in the Division of Bioengineering and Physical Science, National Institute of Biomedical Imaging and Bioengineering, for the characterization of fermentation products, protein purification intermediates, and bulk drug substances. The unit outsources in-process analytical studies, such as peptide mapping and amino acid analysis, when required.
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