Able to accommodate both bacterial and yeast expression systems, the BPDF has >6,000 square feet of GMP cleanroom space. The BPDF’s services range from the preparation of Master Cell Banks to the production of multiple gram quantities of purified Bulk Drug Substance.
In contrast to many similar CMO’s, the BPDF has on-site Water-for-Injection (WFI) production and both ambient and hot WFI loops with drops throughout the facility allowing production of custom buffers and media. The fermentation suite features a 200 L fermentor and associated equipment for high cell density bacterial and yeast production of secreted or intracellular products.
Disc-stack centrifugation or tangential flow filtration (TFF) are available for culture harvest. To lyse cells, a homogenizer and a microfluidizer are available. Downstream process equipment includes a chromatography skid (flow rates ranging from 0.6 – 12 Lpm), as well as multiple TFF systems for concentration/diafiltration operations.