Performing upstream and downstream processing for production of material suitable for pre-clinical and animal toxicology studies, the BPDF provides process optimization and scale-up to commercial manufacturing organizations. Projects range from single one-off fermentations to full upstream and downstream production of multiple gram quantities of purified material. Utilizing microbial expression systems such as Escherichia coli and Pichia pastoris, the BPDF produces recombinant molecules for a wide variety of products, including research material, clinical bulk drug substances suitable for Phase I/II clinical trials, reagents, and product intermediates. Fermentation and purification capabilities allow a wide array of production scenarios.
All manufacturing batches are performed following production batch records to capture critical process information that may be used for process scale-up, technology transfer or support for release of GMP material.
An experienced professional staff creates innovative solutions for successful process scale-up and GMP production utilizing more than 6,000 square feet of clean room space. An in-house Water-For-Injection (WFI) system allows fast preparation of custom buffers and process solutions.