Special Report: Current Analytical Approaches to Biophysical Characterization in a Regulatory Environment

Anshuman Shukla

October 22, 2019

1 Min Read

17-10-Intertek-SR-Cover-221x300.pngStructural integrity of protein-based therapeutics is one of the major challenges in the biopharmaceutical industry. Multiple factors such as product stability, efficacy, and shelf life could be affected following minor changes in manufacturing process. Multiple biophysical methods employing spectroscopic and calorimetric tools can be used to analyse Higher Order Structure (HOS). Moreover, with an increasing demand for generating as much structural information as possible for regulatory submissions, a requirement for these analyses in a GMP environment is also important.

This report focuses on current biophysical analyses that provide a better understanding of a biologic drug and new analytical approaches that are key to a successful program addressing critical quality attributes to support regulatory submissions.

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1 Kaplon H, Reichert JM. Antibodies to Watch in 2019. MAbs 11(2) 2019: 219–238; doi: 10.1080/19420862. 2018.1556465.

2 ICH Harmonised Tripartite Guideline Specifications: Q6B Test Procedures and Acceptance Criteria for Biotechnological/Biological/Biological Products. Fed. Register 64, 1999: 44928; https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf.

3 ICH Harmonised Tripartite Guideline Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process. Fed. Register 70(125) 2005: 37861–37862; https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf.

Anshuman Shukla is a technical expert in biophysics at Intertek
Pharmaceutical Services, [email protected].

This report is based on a webcast with the same title that is available in our archives.

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