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

DATE

May 8, 2025

TIME

8:00 a.m. PDT, 11:00 a.m. EDT, 16:00 BST, 17:00 CEST - Duration: 60 Minutes

Overview

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.

Key Learning Objectives:

Understand the EP regulatory requirements for the instrumental color assessment in detail and how color is evaluated per EP 2.2.2.
Explore the use of Variable Pathlength Technology to perform objective, multiattribute color measurements with reduced sample volumes.
Learn how to streamline quality control workflows and ensure GMP-compliant accuracy for both color and concentration assessments.

Who Should Attend:

This webinar is ideal for professionals working in biopharmaceutical workflows, including:

Analytical Scientists
Quality Control Scientists
Bioprocess Development Engineers
Pharmaceutical Formulation Specialists

Brought to you by:

Speakers

Dr. Michael Galchenko
Bioanalytics Applications Specialist,
Repligen

Melissa O'Meara
Forensic Science Consultant,
C&EN Media Group

Registration

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