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:

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