The BPDF staff includes more than 50 highly trained and experienced personnel, and the advanced equipment and facilities to provide capabilities in the following areas:.

Molecular Biology Work focuses on strain and gene construction in Pichia pastorus and E. coli :

Fermentation Research and Development Capabilities include nine 5 L computer-controlled fermentors, advanced analytical equipment (GC, glucose analyzer, spectrometer), culture maintenance and storage (LN2 dewar), and culture expertise in yeast and bacteria, particularly Pichia pastoris and E. coli .

Purification Research and Development
Capabilities include three BioCads (BC 60 and 700 E) electrophoresis (SDS-PAGE, IEF, Western, 2D) and bench-scale ultrafiltration.

Analytical Research and Development
Work includes performance of in-process and final product tests using HPLCs, GLP, ELISA, and LAL (endotoxin).

Fermentation Pilot Plant and Manufacturing
Capabilities include Phase I cGMP (oral/injectable 8/01), 500L and 80L fermentors, cell harvesting and cell disruption.

Purification Pilot Plant and Manufacturing
Capabilities include a large-scale process chromatography skid,
process columns, and three crossflow membrane filtration systems.

Quality Control / Quality Assurance
Includes implemented GLP (FDL and PDL), implemented GMP (FPP, PPP and QC), raw material control, preseed banks for cultures, cleaning qualification, equipment maintenance, SOPs and batch records, and certificate of analysis for final products.

RiboPrinter® System Characterization
The RiboPrinter® microbial characterization system provides a rapid, standardized method of identifying microbial contaminants efficiently and consistently. The system creates a genetic fingerprint of the organism and compares it against a database of over 6000 patterns. Searching below the species level, it is not only able to identify bacteria but also the relatedness of samples. Our system is fully validated and operates in a GLP laboratory.