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Related Experiment Video

Updated: Jun 2, 2026

PTR-ToF-MS Coupled with an Automated Sampling System and Tailored Data Analysis for Food Studies: Bioprocess Monitoring, Screening and Nose-space Analysis

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Incurred sample reanalysis: failures in macromolecule analysis--insight into possible causes.

Jeffrey M Sailstad¹, Brent E Salfen, Ronald R Bowsher

¹Sailstad & Associates, Inc. 6 Porchlight Court, Durham, NC 27707, USA. sailstad@aol.com

|May 7, 2011

Summary

Incurred sample reanalysis in macromolecule analysis often passes, but studying failures provides valuable community learning opportunities. Analyzing these analytical challenges enhances scientific wisdom and improves methods.

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Area of Science:

Pharmaceutical Analysis
Biopharmaceutical Development
Analytical Chemistry

Background:

Establishing appropriate incurred sample reanalysis (ISR) protocols is crucial in biopharmaceutical development.
Community consensus is growing on ISR procedures, including sample numbers and acceptance criteria.
Learning from ISR failures is essential for advancing analytical science.

Purpose of the Study:

To examine the lessons learned from incurred sample reanalysis (ISR) failures in macromolecule analysis.
To foster a community-wide understanding of challenges and successes in ISR testing.
To highlight the importance of analyzing both successful and unsuccessful ISR outcomes.

Main Methods:

Discussions with industry specialists in macromolecule analysis.
Confidential sharing of incurred sample reanalysis (ISR) failure investigations.
Community-wide reflection on the outcomes of ISR testing.

Main Results:

Most incurred sample reanalysis (ISR) testing in macromolecule analysis proceeds without significant issues.
Specific instances of ISR failures offer valuable learning opportunities for the scientific community.
Analysis of failures provides insights into method robustness and potential sources of variability.

Conclusions:

Scientists gain wisdom through analyzing incurred sample reanalysis (ISR) failures, akin to learning through personal failure.
Sharing ISR challenges and investigations benefits the broader scientific community.
Continuous evaluation of ISR outcomes is vital for improving analytical methodologies and ensuring drug product quality.