Mechanical Stress Testing Assay

The development of biopharmaceuticals has been growing over the past two decades. From the perspective of the structure of the modern pharmaceutical industry, more and more protein drug products have entered the research and development cycle and have even been put into the market. With the continuous improvement of biological therapy, the control and analysis of protein stability is an increasingly important challenge and the key issue for many research groups and companies. Creative Biolabs' drug testing platform provides mechanical stress testing of drugs to help customers screen more stable drug candidates and improve the development of new drugs.

Mechanical Stress and Protein Aggregation

Oligomerization of proteins was studied in detail in the 1960s and described by a simple Lumry-Eyring model. This model has been used in many aggregation experiments and is further elaborated. Protein aggregates are formed between two or more protein molecules. This aggregated protein may be partially folded or unfolded, that is, the difficulty in maintaining the high-order structure leads to the exposure of the hydrophobic region, and promotes the interaction between the molecules to cause aggregation and precipitation.

Aggregation or association can easily occur under a wide variety of conditions where several factors have an influence on the aggregation rate, including protein concentration, temperature, mechanical stress such as shaking and stirring, pumping, and freeze-thaw processes. During manufacturing and transportation, proteins are subjected to high-intensity mechanical or shear stresses by mixing and agitation, and are exposed to various environments. However, the relationship between the mechanical stress of drug proteins and the interaction between proteins and the environment has not yet been elucidated. Each protein drug needs to be tested separately for its stress sensitivity during the actual development process. In order to more closely mimic the “real-life” mechanical stresses which proteins experience during manufacturing, storage and shipping, horizontal or vertical shakers, stirred reactors and pumps are used also as mechanical stress methods.

Mechanical Stress Testing Services

To better understand the size and number of protein aggregates caused by mechanical stress. Creative Biolabs studied the aggregation behavior of monoclonal antibody drugs during agitation at various temperatures. We compared different agitation methods, the effect of different filling volumes on the protein, and the protective effect of different concentrations of excipients on the antibody. We use a range of different analytical techniques for the detection and monitoring of aggregate formation, including turbidity, light shading, SEHPLC, and dynamic light scattering (DLS). In addition, mDSC was used to measure the melting temperature (T_m) of the antibody protein tested. FTIR spectroscopy was used to assess major changes in the secondary structure of precipitated proteins compared to unstressed antibodies.

If you have any questions about our manufacturability assessment service, you can contact us by email or send us an inquiry to find a complete solution.

All listed services and products are For Research Use Only. Do Not use in any diagnostic or therapeutic applications.

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