Campbell, J J; Almond, N; Bae, Y K; Bhuller, R; Briones, A; Cho, S J; Cleveland, M H; Cleveland IV, T E; Galaway, F; He, H-J; Herbrand, U; Huggett, J F; Kempster, S; Kepiro, I E; Khan, A S; Kwee, E; Li, W; Lin-Gibson, S; Luckau, L; Minelli, C; Ryadnov, M G; Searing, I; Wang, L; Whale, A S; Baybrook, J H (2024) Standards and Metrology for Viral Vectors as Molecular Tools : Outcomes from a CCQM workshop. Biologics, 4 (2). pp. 187-201.

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Abstract

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

Item Type:	Article
Keywords:	viral vectors; metrology; standards; measurement; analytical methods; characterisation; physical titre methods; functional titre methods; quantification; reference materials
Subjects:	Biotechnology > Biopharmaceutical Manufacturing and Characterisation
Divisions:	Chemical & Biological Sciences
Identification number/DOI:	10.3390/biologics4020013
Last Modified:	21 Oct 2024 10:42
URI:	https://eprintspublications.npl.co.uk/id/eprint/10080