Protein Mass Spectrometry
BioPharmaSpec provides protein characterization and sequencing services for your biopharmaceutical. From our globally located analytical testing labs in the US and Europe, BioPharmaSpec scientists apply high resolution mass spectrometry expertise to a wide range of novel and biosimilar molecules such as recombinant proteins, antibodies, antibody drug conjugates (ADCs), fusion proteins and bispecifics to characterize them according to the ICH guidelines.
Mass Spectrometry Analysis
BioPharmaSpec experts understand the complexity of (glyco)protein structure and will customize a wide range of mass spectrometry techniques and strategies to provide you with high-quality protein and glycan characterization information.
- Intact molecular weight analysis
- Primary (de novo) amino acid sequence
- Peptide mapping
- analysis of PTMs including disulfide bridges
- sites of attachment N- and O-linked glycans
- Glycan analysis
- including monosaccharide composition and linkage and N and O oligosaccharide profiling.
- Protein identification and quantitation
Many of the above methods are recommended in the ICH guidelines, which should be followed when characterizing a protein according to globally accepted regulations. For a full description of the protein characterization methods required under these guidelines, please visit our protein characterization pages.
Impurity Analysis Services
The ICH guidelines also state that you must demonstrate the absence of any contaminants, such as process related impurities. Such impurities include reagents such as inducers and antibiotics or downstream derived contaminants such as solvents or enzymes.
BioPharmaSpec uses Mass Spectrometry to develop and optimize methods for the detection of process related impurities in your product. Mass Spectrometry is a highly sensitive and selective technique capable of detection down to low ppm/ppb levels. In our global laboratories, we use HPLC-ELSD, GC-MS, LC-MS and LC-MS/MS (MRM) to provide an extensive range of analytical methods to identify and quantify these residuals, allowing you to demonstrate that your downstream process is reducing or removing these chemicals effectively.
Host Cell Protein Analysis
Host Cell Proteins (HCPs) originate from the production cell line and are removed from the final product via purification, but it is likely a small amount of HCP contaminants will remain. These HCPs must be monitored throughout the process and in your final product.
Host Cell Protein Mass Spectrometry (HCP-MS) is a proteomic approach that does not require specialized antibody reagents and serves to expand identification of HCPs and quantitation of each individual protein. When LC-MS is used alongside your commercial ELISA kit, you will increase coverage of the total HCP population in any sample, so that you are detecting more of the Host Cell Proteins throughout your process and in your product.
An advantage that LC-MS based methods have over ELISA is that they will enable you to identify and quantify individual HCPs that are present at different stages of your process. Armed with this knowledge, you can track HCPs of concern, such as enzymatic or immunogenic proteins, and develop robust removal strategies.
BioPharmaSpec’s approach to HCP-MS is flexible and proceeds through clearly defined stages, meaning that you receive data that is useful and applicable at your stage of product development and allows you to meet your specific objectives.
We are the Mass Spec experts
BioPharmaSpec scientists have been at the forefront of mass spectrometry for over four decades, contributing to pioneering research and the industry's regulations. Talk to an expert now for some mass spec advice.