Analysis of protein, enzyme and biological pharmaceuticals

Are you working with research on or production of proteins, enzymes, or biological pharmaceuticals? We offer advanced, strategic, and experimental analysis support for you to fully understand your protein. We support projects in both early and late preclinical phases, as well as in the clinic, and can support you with protein analysis either within a single analysis context, to meet specific analytical needs, or as analytical support through process development.

When working with biological pharmaceutical products, early characterization of the selected pharmacological target has been identified as one of the most important success factors, resulting in reduction of both project time and costs.  The ability to rapidly identify stability issues, detect modifications and identify contaminants at an early stage of product development, are all key to effective process development of biological products, where toxic, unstable or inactive substances can be deselected at an early stage. At RISE, we are specialized in numerous protein analysis techniques such as high resolution mass spectrometry (LC-MS, LM-MS/MS), chromatography (LC-UV, SEC, RP, IEX), electrophoresis (SDS-PAGE) and spectrophotometric methods and ELISA. With our help, you can rapidly gain insight into:

• What molecular weight does the target protein and other protein related substances have? Is it in line with what is expected?
• Is the protein intact?
• Is the protein truncated?
• What is the purity grade in the sample?
• Is the amino acid sequence correct? A peptide map, where the protein is degraded with one or more enzymes followed by LC-MS/MS analysis could give the answer.
• Is the protein active?
• Is the protein stable?
• Does the protein aggregate?
• What charge profile does the protein possess?
• Are there post translational modifications (for example glycosylation, phosphorylation, oxidation, deamidation) and, if so, where and what kind are they?
• Is the protein homogenous or heterogenous?
• What other protein species are present in the sample, apart from the target protein?

If you have a protein analytical challenge, we will help you find the best strategy and methods to provide the right data to answer your question. In doing this, RISE can offer advice and support to meet quality and regulatory requirements from authorities such as FDA and EMA. Do not hesitate to contact us if you wish to discuss your project further.