The Purification Development Laboratory (PDL) has the responsibility of purification research and development and is focused primarily on biotherapeutic molecules that are destined for human clinical trials. The PDL is well-equipped for purification research and development. Equipment includes 5 Applied Biosystems Chromatography Workstations that are capable of 0 to 100 ml/min flow rate with online measurement of UV (2 wavelenghts), 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 of membrane area. The PDL is also equipped with all of the standard laboratory equipment to support protein purification.
Capabilities
The PDL is capable of developing all aspects of a purification process, starting with a fermentation extract. The PDL has experience with just about any chromatrography resin or chemistry, expanded bed adsorption chromatography, ultrafiltration, all forms of electrophoresis, and ELISA. The PDL has on numerous occasions successfully developed and transitioned a purification process to the pilot-scale for both GMP and non-GMP production.
Equipment
Major equipment include three Perseptive Biosystems BioCad Workstations, ISCO prep HPLC system, gel scanning system w/ computer and software, Dynex ELISA workstation w/ computer and software, electrophoresis equipment, and a Biospec cell disruption system and an EH-110 Microfluidizer for cell disruption.
