Laureate Pharma of the USA has commissioned a new automated chromatography system for Good Manufacturing Practice-compliant purification of protein products. The unit is specifically designed for biopharmaceutical purification applications, featuring polymeric, sanitary flowpaths and an array of detectors.
In the coming months, the company also plans to install and validate a larger-scale chromatography system to purify protein products produced in its 2,000-liter mammalian cell bioreactor.
"Combined with our process development and manufacturing expertise, this automated, validated, and [21 CFR] Part 11-compliant system offers our clients the confidence that their biopharmaceutical product will be purified accurately and consistently in compliance with cGMPs," said Bruce Weaver, who heads the firm's protein purification business.
In addition to supporting the production needs of its clients, Laureate also foresees new opportunities for the system in the purification of feedstock from transgenic protein-production sources.