Able to accommodate both bacterial and yeast expression systems, the BPDF has non-GMP Fermentation and Purification Development Laboratories as well as >6,000 square feet of classified GMP cleanroom space with a minimum classification of ISO 8. The purification areas are ISO 7 and Biological Safety Cabinets located in the purification and fermentation areas are ISO 5. The BPDF’s services range from the preparation of Research and Master Cell Banks to the production of multiple gram quantities of purified Bulk Drug Substance for early clinical phase studies.
In contrast to many similar CDMO’s, the BPDF has a dedicated on-site Water-for-Injection (WFI) production system with both ambient and hot WFI loops with drops throughout the facility allowing production of custom buffers and media, as well as dedicated steam and process gas lines. All critical processing and storage equipment is connected to an uninterruptible power supply (UPS), which is further supported by an emergency back-up generator.