The Purification Development Laboratory conducts purification research and development on biotherapeutic molecules that are destined for human clinical trials.
Capable of all aspects of a purification process, the PDL has successfully developed and transitioned numerous purification processes to the pilot-scale for both GMP and non-GMP production.
The PDL has experience with chromatrography resin, chemistry, expanded bed absorption chromatography, ultrafiltration, all forms of electrophoresis, and ELISA.
In addition to standard laboratory equipment, PDF facilities include:
- 6 Applied Biosystems Chromatography Workstations capable of 1 to 100 ml/min flow rate with online measurement of UV (2 wavelengths), pH and conductivity.
- Cell disruption capabilities from bench to pilot scale, including a APV Gaulin CD30 homogenizer with an operating pressure of 15,000 psig and a Microfluidic EH-110 microfluidizer with an operating pressure up to 25,000 psig.
- Four cross flow membrane filtration systems from North Carolina SRT that can handle from 0.3 L to 200 L of processing volume with membrane areas of 0.1 to 5 m2.
Equipment
- NCSRT Model 50 Ultrafiltration / Diafiltration Skid
- NCSRT Model 10 Ultrafiltration / Diafiltration Skid
- 4 PerSeptive BioSystems Vision Chromatography Systems
- 2 PerSeptive BioSystems BioCad Chromatography Systems
- Beckman Coulter DU 46 Spectrophotometer
- 2 Microfluidics Microfluidizer Processors
- APV Gaulin, Inc Homogenizer