Downstream Processing

Protein Purification
At Laureate, we use automated chromatography development systems to scale up from bench to manufacturing, develop robust well-integrated processes and produce high purity product with good yield. From sample preparation to initial capture to polishing and final product formulation, our experienced team can purify any protein product to full cGMP requirements. We have custom designed methods to purify a variety of protein-based therapeutics using various chromatography and filtration techniques. In appropriate cases we also use disposable charged membrane cartridges in lieu of column chromatography for purification. Our column sizes vary to accommodate feed volumes, protein concentration and binding capacity of the resins. Some of the techniques we use include:

• Affinity
• Ion exchange
• Hydrophobic Interaction
• Size exclusion
• Tangential Flow Filtration
• Diafiltration
• Ultrafiltration

We purify and manufacture protein-based therapeutics using semi automated chromatography skids with flow capabilities ranging from 2L/min to 30L/min. Our purification experts have routinely purified hundreds of grams to Kilogram quantities of proteins. We perform process validation, including viral clearance studies at off-site qualified laboratories.

Protein Modification and Conjugation
The scientists at Laureate have the unique capability and track record in developing radiolabeled antibodies for cancer therapy. Such antibodies have enhanced potency in cancer therapy, directing potent radiation to specific areas of disease. Process development and cGMP manufacturing for clinical trials of these entities, however, pose logistical challenges.

At Laureate, we have a team of specialists who can perform chemical conjugation of molecules with proteins for clinical and commercial scale and have special expertise in working with conjugation of chelators to proteins for radiolabelling. We have an ongoing manufacturing contract producing commercial scale radiolabeled antibodies for a biopharmaceutical company.

Analytical Development
Our team of scientists based on clients' requirements, routinely characterize protein properties, develop assays and test methods, transfer in client's methods, and/ or adapt Laureate Pharma's methods to clients' protein products. We develop formulation that optimizes product quality and stability. We perform the following tests routinely on the protein products:

• Electrophoretic assays
  • SDS PAGE, IEF
• Immuno assays
  • ELISA, RIA
• Chromatographic assays
  • HPLC assays with RI & UV detectors
  • GC with FID and TCD detectors
• Endotoxin Removal assays
  • Gel clot, Kinetic