C&EN Webinar

EP 2.2.2 for mAbs: Instrumental Color Assessment using Variable Pathlength Spectroscopy

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On Demand

TOPICS:

Analytical Chemistry
Biological & Medicinal Chemistry

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Color assessment is a critical quality control step in pharmaceutical manufacturing, especially for monoclonal antibody (mAb) solutions. However, traditional methods such as visual inspection and single-pathlength colorimetry are prone to subjectivity, inconsistencies, and limited accuracy. Variability in lighting, observer perception, and a lack of built-in validation tools contribute to unreliable results that can jeopardize regulatory compliance and batch release decisions. These limitations become even more problematic when working with highly colorized samples, low volumes, or processes requiring high precision and reproducibility.

This webinar introduces a more advanced, EP 2.2.2-compliant approach using Variable Pathlength Technology (VPT) with the CTech SoloVPE PLUS System. By automatically optimizing pathlength based on optical density and incorporating a built-in linearity check, VPT enables accurate, objective, and reproducible color measurements—even at low sample volumes. Learn how this multiattribute method not only eliminates the need for baseline correction but also consolidates color and concentration testing into a single workflow, dramatically improving efficiency while supporting GMP-level quality control.

Speakers

Dr. Michael Galchenko

Bioanalytics Applications Specialist, Repligen

ACS Institute

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