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Interlaboratory Studies Using the NISTmAb to Advance Biopharmaceutical Structural Analytics.
Katharina Yandrofski1, Trina Mouchahoir1, M Lorna De Leoz2
1Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology, Rockville, MD, United States.
Frontiers in Molecular Biosciences
|May 23, 2022
Summary
Interlaboratory studies using NISTmAb characterized monoclonal antibody (mAb) analytical methods. These studies assessed method performance for critical quality attributes, ensuring biopharmaceutical safety and efficacy.
Area of Science:
- Analytical Chemistry
- Biopharmaceutical Analysis
- Biotechnology
Background:
- Biopharmaceuticals, like monoclonal antibodies (mAbs), necessitate comprehensive analytical characterization.
- Controlling material properties is crucial for maintaining critical quality attributes (CQAs) and clinical relevance.
- Understanding analytical method performance is essential for ensuring drug safety, stability, and functional activity.
Purpose of the Study:
- To evaluate the performance of state-of-the-art analytical methods for biopharmaceutical characterization.
- To harmonize best practices in analytical method application for monoclonal antibodies.
- To identify potential gaps in the analytical measurement infrastructure for biopharmaceutical development.
Main Methods:
- Utilized NISTmAb, a well-characterized monoclonal antibody reference material.
- Conducted a series of interlaboratory studies involving multiple analytical laboratories.
- Focused on methods for assessing primary structure, post-translational modifications, and higher-order structure.
Main Results:
- Reported on the performance metrics of various analytical methods applied to NISTmAb.
- Identified areas of agreement and variability in measurements across different laboratories.
- Provided insights into the current capabilities and limitations of analytical techniques for mAb characterization.
Conclusions:
- The interlaboratory studies provide a benchmark for analytical method performance in biopharmaceutical characterization.
- Harmonizing practices and addressing measurement gaps are critical for reliable biopharmaceutical quality control.
- Continued evaluation of analytical methods is necessary to support the development of safe and effective biotherapeutics.
