Protein-based pharmaceuticals are one of the fastest growing group therapeutic agents. Compared with small molecule drugs, recombinant protein therapeutics require more strict control in bio-synthesis, purification and storage steps. In addition, regulatory authorities and relevant industry guidelines (ICH Q6B) recommend to monitor changes in the product as a result of manufacture and/or storage, including protein aggregate.
What Is Protein Aggregation?
Figure 1. Schematic diagram illustrating multiple non-native aggregation pathways for a multidomain protein (Roberts C J., 2014)
Protein aggregation, sometimes also known as non-native aggregation, refers to the process by which protein molecules assemble into stable complexes composed of two or more proteins. The aggregation of protein therapeutics is the most common and troubling manifestation during R & D, because protein aggregates usually exhibit reduced or no biological activities since the medical biologics are functional only in the native state; more importantly, they might show stronger immunogenicity/cellular toxicities. Protein aggreation may occur during multiple stages of the manufacturing process of protein therapeutics, including fermentation, purification, formulation and storage.
Given the instability and degradation, there is the high tendency of macromolecules to aggregate under the processing and storage conditions. So, the protein aggregation must be controlled strictly to a satisfactorily low level before commercialized.
Protein Aggregation Analysis at Creative Proteomics
At Creative Proteomics, we have developed a professional platform for protein aggregation analysis that contains various techniques, including but not limited to:
With our professional platform, we can provide various information by combining with our expertise in the field of protein structure-function to help you find solutions to problems along the product development. The information include but are not limited:
We have extensive experience to analyze protein aggregates by using multiple technologies. Based on professional knowledge and experienced staff, Creative Proteomics provides high-resolution 2-DE for separating all kinds of proteins. Our ordering procedure is as follows. If you have any questions or specific needs, please don’t hesitate to contact us.
1. Roberts C J. Therapeutic protein aggregation: mechanisms, design, and control. Trends in biotechnology, 2014, 32(7): 372-380.