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Related Concept Videos

Affinity Chromatography01:03

Affinity Chromatography

752
Affinity chromatography is a powerful technique extensively utilized for separating and purifying specific biomolecules from complex mixtures. It capitalizes on the highly selective binding between an analyte and its counterpart, such as antibody-antigen interactions. The counterpart is immobilized on the stationary phase, forming an affinity column. The stationary phase typically consists of solid support, such as agarose or porous glass beads, immobilizing the affinity ligand. The mobile...
752
Deleterious Substances in Aggregate01:25

Deleterious Substances in Aggregate

211
Deleterious substances in aggregates can be detrimental to the quality and durability of concrete. These substances include organic impurities like loam, which interfere with cement hydration and are usually present in the sand. These prevent a good bond between aggregate and cement paste. Organic impurities can be detected using the colorimetric test, where the darkness of a solution after agitation indicates the level of organic content.
Another type of impurity is clay and fine material that...
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
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Updated: Jul 23, 2025

Activated Cross-linked Agarose for the Rapid Development of Affinity Chromatography Resins - Antibody Capture as a Case Study
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A Risk-Based Approach for Managing Affinity Resin Contaminations.

Beth Fulton1, Angelica Welch2

  • 1ValSource Inc. bfulton@valsource.com.

PDA Journal of Pharmaceutical Science and Technology
|July 14, 2023
PubMed
Summary

This commentary presents a method for cleaning contaminated affinity resins. It includes a risk assessment tool to ensure safe resin reuse after remediation.

Keywords:
Affinity resinBioburdenBiofilmChromatographyContaminationProtein ARBIARisk-based impact assessment

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Area of Science:

  • Biotechnology
  • Chemical Engineering
  • Process Chemistry

Background:

  • Affinity resins are critical in bioprocessing for purification.
  • Contamination necessitates remediation (non-routine sanitization) before resin reuse.
  • Assessing the risk of reused resins is essential for process integrity.

Purpose of the Study:

  • To propose a systematic approach for affinity resin remediation.
  • To present a methodology for information gathering and decision-making in resin cleaning.
  • To introduce a tool for evaluating the process risks of returning remediated resins to use.

Main Methods:

  • Literature review and expert consensus on remediation strategies.
  • Development of a structured decision-making framework.
  • Creation of a risk assessment tool for remediated resin return-to-use.

Main Results:

  • A comprehensive approach to affinity resin remediation is outlined.
  • A clear methodology for data collection and decision-making is provided.
  • A practical tool for assessing the risk of using remediated resins is presented.

Conclusions:

  • Effective remediation protocols are vital for sustainable bioprocessing.
  • A structured risk assessment enhances the safety and reliability of reused affinity resins.
  • The proposed approach facilitates informed decisions regarding affinity resin reuse post-sanitization.