We support the development of all the required product-specific release and stability-determining assays for your recombinant protein.
With an increasing number of complex large molecules under investigation such as, integral membrane proteins, enzymes, and antibody constructs of various types, the importance of having reliable, accurate and sensitive assays is paramount.
We are working on many different projects every year, and quality control is ingrained into our thinking, procedures and actions. Undoubtedly, a meticulous and critical attitude towards testing on the quality of protein preparations significantly increases the chances of success in subsequent experiments.
The Analytical Team is constantly expanding our repertoire of assays to meet the evolving needs of the biopharmaceutical industry and our clients. We also work with a network of partners that are specialized in some aspects of protein quality assessment. This allows us to seamlessly integrate the experience of our partners our customer’s projects.
To evaluate cell specific productivities and overall expression levels of recombinantly expressed proteins, we employ commercially validated or in-house developed product-specific, HPLC-based or ELISA-based assays. Product quality, purity and specificity is determined using standard biochemical assays such as SDS-PAGE (reduced, non-reduced, glycosylated and de-glycosylated) and western blot. Potency is evaluated by in vitro and cell-based assays, developed in-house, transferred-in from customer’s previously executed development work or using commercially validated kits. In case of recombinant antibodies, we utilize HPLC-based residual protein-A analyses to determine purity and analytical size exclusion chromatography to determine the fraction of monomers expressed. Presence and the relative abundance of different glycomers is determined using IEX-HPLC and/or IEF analyses. N-glycan analysis and sialic acid quantitation assays are used to provide a more complete picture of the biochemical properties of proteins. Finally, host-cell protein, host-cell DNA, and endotoxin assays are used to monitor process related impurities or terminal quality control testing.
In addition to our set of ready-to-go assays based on our SOP system, we are well equipped to develop new assays and have an excellent track record in successfully transferring customer-developed assays for further development, optimization, qualification and validation.