The Quality Control laboratory provides microbiological services to the BPDF, including environmental monitoring of the cGMP facilities and microbiological release tests for Master Cell Banks and Working Cell banks.
The Quality Control Laboratory is an FDA compliant laboratory that serves the analytical methods needs of the BPDF with all methods performed using approved SOPs. Capabilities include: HPLC with UV, photodiode array, and evaporative light scattering detectors; capillary electrophoresis with UV and fluorescence detectors; gas chromatography with FID detectors; and microtiter plate reader with scanning UV and fluorescence detection.
QC uses standard equipment to perform routine microbiology and sterility tests. QC also has a Qualcon Riboprinter®, an automated system that identifies bacteria. All equipment is validated and all methods follow approved Standard Operating Procedures.
Other capabilities include: FTIR, total organic carbon, LAL (endotoxin), ELISA, standard protein determination and electrophoresis, SDS-PAGE, Western blot, IEF, and 2-D SDS PAGE.
- Bruker Tensor 37 FTIR
- Molecular Devices Spectramax
- Beckman Coulter P/ACE MDQ
- Sievers 900 TOC Analyzer
- Waters Alliance 2695 Separations Module
- 2 Waters 2487 Dual Absorbance Detectors
- 2 Waters 717 Plus Autosamplers
- Waters 486 Tunable Absorbance Detector
- 2 Waters 600 System Controllers
- Pyros Kinetix Endotoxin Detection System
- Agilent 2100 Bioanalyzer
- Dionex Ultimate 3000 Micro HPLC System
- Dionex Ultimate 3000 Standard HPLC System