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Conference Report

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

by
Jonathan J. Campbell
1,*,
Neil Almond
2,
Young-Kyong Bae
3,
Ravneet Bhuller
2,
Andrea Briones
4,
Sang-Joon Cho
5,
Megan H. Cleveland
6,
Thomas E. Cleveland IV
6,7,
Francis Galaway
8,
Hua-Jun He
6,
Ulrike Herbrand
9,
Jim F. Huggett
1,
Sarah Kempster
2,
Ibolya E. Kepiro
4,
Arifa S. Khan
10,
Edward Kwee
6,
Wilson Li
11,
Sheng Lin-Gibson
6,
Luise Luckau
1,
Caterina Minelli
4,
Maxim G. Ryadnov
4,
Isobel Searing
12,
Lili Wang
6,
Alexandra S. Whale
1 and
Julian H. Braybrook
1,*add Show full author list remove Hide full author list
1
National Measurement Laboratory Hosted at LGC Limited, Queens Road, Teddington TN1 10LY, UK
2
Medicines and Healthcare Products Regulatory Agency, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK
3
Korea Research Institute of Standards and Science, 267 Gajeong-Ro, Yuseong-Gu, Daejeon 34113, Republic of Korea
4
National Physical Laboratory, Hampton Road, Teddington TW11 0LW, UK
5
Park Systems Corp., 109, Gwanggyo-ro, Yeongtong-gu, Suwon-si 16229, Republic of Korea
6
National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899, USA
7
Institute for Bioscience and Biotechnology Research, Rockville, MD 20850, USA
8
Medicines and Healthcare Products Regulatory Agency, 10 South Colonnade, Canary Wharf, London E14 4PU, UK
9
Charles River Laboratories Germany GmbH, Max-Planck-Straße 15 A, 40699 Erkrath, Germany
10
Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
11
Cell and Gene Therapy Catapult, 12th Floor Tower Wing, Guy’s Hospital, Great Maze Pond, London SE1 9RT, UK
12
Oxford Biomedica (UK) Ltd., Windrush Court, Transport Way, Oxford OX4 6LT, UK
 
add Show full affiliation list
 
remove Hide full affiliation list
*
Authors to whom correspondence should be addressed.
Biologics 2024, 4(2), 187-201; https://doi.org/10.3390/biologics4020013
Submission received: 3 April 2024 / Revised: 16 May 2024 / Accepted: 20 May 2024 / Published: 24 May 2024
Versions Notes

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.
Keywords: viral vectors; metrology; standards; measurement; analytical methods; characterisation; physical titre methods; functional titre methods; quantification; reference materials viral vectors; metrology; standards; measurement; analytical methods; characterisation; physical titre methods; functional titre methods; quantification; reference materials

Share and Cite

MDPI and ACS Style

Campbell, J.J.; Almond, N.; Bae, Y.-K.; Bhuller, R.; Briones, A.; Cho, S.-J.; Cleveland, M.H.; Cleveland, T.E., IV; Galaway, F.; He, H.-J.; et al. Standards and Metrology for Viral Vectors as Molecular Tools: Outcomes from a CCQM Workshop. Biologics 2024, 4, 187-201. https://doi.org/10.3390/biologics4020013

AMA Style

Campbell JJ, Almond N, Bae Y-K, Bhuller R, Briones A, Cho S-J, Cleveland MH, Cleveland TE IV, Galaway F, He H-J, et al. Standards and Metrology for Viral Vectors as Molecular Tools: Outcomes from a CCQM Workshop. Biologics. 2024; 4(2):187-201. https://doi.org/10.3390/biologics4020013

Chicago/Turabian Style

Campbell, Jonathan J., Neil Almond, Young-Kyong Bae, Ravneet Bhuller, Andrea Briones, Sang-Joon Cho, Megan H. Cleveland, Thomas E. Cleveland, IV, Francis Galaway, Hua-Jun He, and et al. 2024. "Standards and Metrology for Viral Vectors as Molecular Tools: Outcomes from a CCQM Workshop" Biologics 4, no. 2: 187-201. https://doi.org/10.3390/biologics4020013

APA Style

Campbell, J. J., Almond, N., Bae, Y.-K., Bhuller, R., Briones, A., Cho, S.-J., Cleveland, M. H., Cleveland, T. E., IV, 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., ... Braybrook, J. H. (2024). Standards and Metrology for Viral Vectors as Molecular Tools: Outcomes from a CCQM Workshop. Biologics, 4(2), 187-201. https://doi.org/10.3390/biologics4020013

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