Our experience in large molecule characterization and conjugate synthesis gives us the tools to be successful in delivering optimal product stability and bioactivity for our clients’ large molecule projects. It is well known that long-term stability and biological activity of large molecules is dependent upon maintenance of the protein’s native three-dimensional conformation. We use biophysical characterization techniques to assess the conformational and thermodynamic stability of proteins under a range of formulation processes.
These tools allow us to differentiate among various buffer, pH, ionic strength and excipient conditions. They also allow us to identify the conditions that confer the optimal environment for the therapeutic protein in its formulation and in the vehicle of use.
Services/Capabilities:
- Assay/purity/degradation/aggregation
- Activity assessments
- Molecular weight and shape
- Cell based bioassays
- Specific binding assays
- ELISA and Western Blot
- Amino acid analysis
- Peptide mapping
- Capillary and gel electrophoresis
- Gel permeation chromatography
- High resolution LC/MS/MS