抗体の安定性：バイオ医薬品開発における課題と解決策

Ensuring antibody stability is crucial during antibody generation and utilization, as instability can lead to reduced yields, lower efficacy, harmful immune reactions, patient-associated complications, and limited or lost function when working in extreme conditions or during long-term storage.  

The main factors affecting stability are the antibody’s format, structure, state of aggregation, and susceptibility to proteases. There are several methods to monitor the retention of biological function, including ELISA, Western blotting and affinity analysis (e.g. SPR/Biacore), during and after production. Additionally, circular dichroism, nuclear magnetic resonance, and mass spectroscopy have been used to indicate stability in the past.¹

To overcome these issues with stability, one should strive to: 

• Eliminate or minimize proteolysis, fragmentation or aggregation during antibody production. 

• Stabilize the antibody format at the molecular level through sequence or domain swapping, CDR grafting, insertion of additional disulfide(s), or other chemical modifications. 

• Ensure the use of appropriate buffers, additives and excipients. 

• Carefully consider storage conditions including container, temperature, and moisture. 

Stability directly impacts an antibody’s efficacy, safety, and shelf life, making it a critical aspect of biologics development. At Biointron, we are dedicated to accelerating antibody discovery, optimization, and production. Our team of experts can provide customized solutions that meet your specific research needs. Contact us to learn more about our services and how we can help accelerate your research and drug development projects. 

References:

1. Ma, H., Ó’Fágáin, C., & O’Kennedy, R. (2020). Antibody stability: A key to performance - Analysis, influences and improvement. Biochimie, 177, 213-225. https://doi.org/10.1016/j.biochi.2020.08.019