Process Development Unit

The Process Development Unit aims to develop 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 the 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, multiangle 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 NIH’s Biotechnology Unit, National Institute of Diabetes and Digestive and Kidney Diseases, the Research Technology Branch, NIAID, and the Molecular Interactions Resource, Division of Bioengineering and Physical Science 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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