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A systematic and sensitive method for critical reagent antibody evaluation with PCA technology.

Jian Gong1, Xing Wang2, John Hackmann2

  • 1Pharmaceutical & Biological Engineering Department, Zibo Vocational Institute, Zibo, Shandong, 255300, China.

Bioanalysis
|February 17, 2023
PubMed
Summary

Protein conformational array (PCA) ELISA is a sensitive method for quality control of antibodies. This study demonstrates its ability to monitor antibody structure changes during storage and freeze-thaw cycles, ensuring reagent quality.

Keywords:
ELISAcritical reagent managementhigher order structure (HOS)monoclonal antibodiesprotein conformational array (PCA) technology

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Area of Science:

  • Biotechnology
  • Immunology
  • Analytical Chemistry

Background:

  • Quality control of critical reagents is vital for basic research and drug development.
  • Protein conformational array (PCA) ELISA is an established technology for developing biologics, known for its sensitivity and accuracy.

Purpose of the Study:

  • To evaluate the utility of PCA ELISA for assessing antibody quality under various stress conditions.
  • To investigate the impact of storage and freeze-thaw cycles on antibody higher-order structure.

Main Methods:

  • Utilized Protein conformational array (PCA) ELISA to monitor higher-order structure changes in antibodies.
  • Exposed mouse and rabbit antibodies to different storage durations (short- and long-term) and multiple freeze-thaw cycles.
  • Assessed structural integrity of antibodies and antiserum.

Main Results:

  • PCA ELISA effectively monitored higher-order structure changes in antibodies under stress.
  • The study analyzed the effects of various storage conditions and freeze-thaw cycles on antibody structure.
  • Data demonstrated PCA ELISA's capability to detect structural alterations.

Conclusions:

  • Protein conformational array (PCA) ELISA is a valuable tool for antibody quality testing.
  • The method provides accurate assessment of antibody structural integrity.
  • PCA ELISA supports the quality control of critical reagents in research and biopharmaceutical development.