Standards and Metrology for Viral Vectors as Molecular Tools: Outcomes from a CCQM Workshop

Published

May 24, 2024

Author(s)

Janathan Campbell, Neil Almond, Y Bae, Ravneet Bhuller, Andrea Briones, S-Y CHO, Megan Cleveland, Thomas Cleveland, Francis Galaway, Hua-Jun He, U Herbrand, Jim Huggett, Sarah Kempster, Ibolya Kepiro, Afifa Khan, Edward Kwee, Wilson Li, Sheng Lin-Gibson, Luise Luckau, Caterina Minelli, M Ryadnov, I Searing, Lili Wang, Alexandra Whale, Julian Braybrook

Abstract

Viral vectors are agents enabling gene transfer and genome editing and have widespread utility across the healthcare and biotechnology sectors. In January 2023, the International Bureau for Weights and Measures' Consultative Committee for Amount of Substance (CCQM) held a workshop on Metrology for Viral systems as molecular tools. The workshop brought together international leaders from across regulatory, industry, government science, and metrology sectors to better understand key challenges for the community: Exploring current limitations in the measurement of virus-derived, virus-based, and virus-like systems in terms of quantification and characterisation; surveying the state-of-the-art in analytical methods and reference material provision for these entities; and initiating a dialog for the strategic development and implementation of suitable standardisation approaches for this sector. This article presents the workshop background and rationale, presentation summaries, conclusions, and recommendations.

Citation

Biologics

Volume

4

Issue

2

Pub Type

Journals

Download Paper

https://doi.org/10.3390/biologics4020013

Local Download

Keywords

Viral vectors, Gene therapy, Standards, Metrology, Critical quality attributes, CCQM

Citation

Campbell, J. , Almond, N. , Bae, Y. , Bhuller, R. , Briones, A. , CHO, S. , Cleveland, M. , Cleveland, T. , Galaway, F. , He, H. , Herbrand, U. , Huggett, J. , Kempster, S. , Kepiro, I. , Khan, A. , Kwee, E. , Li, W. , Lin-Gibson, S. , Luckau, L. , Minelli, C. , Ryadnov, M. , Searing, I. , Wang, L. , Whale, A. and Braybrook, J. (2024), Standards and Metrology for Viral Vectors as Molecular Tools: Outcomes from a CCQM Workshop, Biologics, [online], https://doi.org/10.3390/biologics4020013, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=957497 (Accessed November 20, 2024)