Laureate Pharma L.P. is expanding its GMP purification capacity for protein biopharmaceuticals by commissioning a new, automated chromatography system.
The new unit features polymeric, sanitary flowpaths and an array of detectors. Over the next few months, the company expects to install and validate an identically configured, larger scale chromatography system for purifying protein products produced in its 2,000-L mammalian cell bioreactor.
The combination of these units offers seamless scaling to support Laureate’s bioreactor production operations. As Bruce Weaver, Manager of Protein Purification at Laureate points out: "Combined with our process development and manufacturing expertise, this automated, validated, and Part 11 compliant system offers our clients the confidence that their biopharmaceutical product will be purified accurately and consistently in compliance with cGMPs."
Laureate Pharma is a privately held contract manufacturing services company with headquarters in Princeton, NJ. Laureate Pharma’s biopharmaceutical division, offers a wide range of product development services from process design and development to full-scale cGMP production, purification and aseptic filling, as well as corresponding analytical services and regulatory support. The division is focused on two active segments of the biopharmaceutical industry: monoclonal antibodies and recombinant protein products.
Keywords : Laureate Pharma Princeton NJ USA Biomanufacturing GMP purification Protein biopharmaceuticals Contract manufaturing Mammalian cell culture Recombinant protein Monoclonal antibodies
