Protea Biosciences Group announced it has integrated its therapeutic antibody analytical methods with new software developed by its partner, Protein Metrics, to automate the detailed analysis of the antibody's structure. The results were presented at the 65th American Society for Mass Spectrometry Conference on Mass Spectrometry and Allied Topics recently held in Indianapolis, Indiana.
"We are pleased to announce these new bioanalytical capabilities. In producing therapeutic antibodies, it's all about understanding the detail of the molecule – for example, discovering molecular deviations caused by such things as shuffled disulfide bond arrangements, glycosylations, and other post translational modifications is extremely important for the final function of the protein," David Halverson, Protea's President said. "Even small changes in the therapeutic structure can have drastic impacts on the function and efficacy of the molecule, and it is often the case that multiple deviations of the antibody's desired structure occur during production."
Protea's new methods can identify therapeutic antibody deviations and impurities, in the form of host cell proteins that may occur as part of the recombinant protein production process. Peptide maps of therapeutic antibodies containing post translational modifications, or the subtle changes of protein structure that occur after synthesis, can now be generated simultaneously while also determining the amount of other impurities present, at extremely low levels. This information is vital for optimizing the entire therapeutic antibody production process. Using the automated analytical method to identify post translational modifications, while simultaneously determining the levels of deviations and impurities, increases the efficiency of manufacturing and generates better analytical results, in less time.
The development and commercialization of therapeutic antibodies is one of the fastest growing areas within the biopharmaceutical industry. Therapeutic antibodies have high efficacy and specificity, due to the ability to accurately synthesize, purify, and verify that the final product does not contain molecular deviations or host cell protein impurities, which could cause an undesired immunogenic response in the patient.