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

Affiliation
National Measurement Laboratory Hosted at LGC Limited, Queens Road, Teddington TN1 10LY, UK
Campbell, Jonathan J.;
ORCID
0000-0001-6105-0616
Affiliation
Medicines and Healthcare Products Regulatory Agency, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK
Almond, Neil;
Affiliation
Korea Research Institute of Standards and Science, 267 Gajeong-Ro, Yuseong-Gu, Daejeon 34113, Republic of Korea
Bae, Young-Kyong;
Affiliation
Medicines and Healthcare Products Regulatory Agency, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK
Bhuller, Ravneet;
Affiliation
National Physical Laboratory, Hampton Road, Teddington TW11 0LW, UK
Briones, Andrea;
ORCID
0000-0003-4822-5658
Affiliation
Park Systems Corp., 109, Gwanggyo-ro, Yeongtong-gu, Suwon-si 16229, Republic of Korea
Cho, Sang-Joon;
ORCID
0000-0002-5584-9314
Affiliation
National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899, USA(H.-J.H.);
Cleveland, Megan H.;
ORCID
0000-0003-1992-8450
Affiliation
National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899, USA(H.-J.H.);
Cleveland, Thomas E.;
Affiliation
Medicines and Healthcare Products Regulatory Agency, 10 South Colonnade, Canary Wharf, London E14 4PU, UK
Galaway, Francis;
Affiliation
National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899, USA(H.-J.H.);
He, Hua-Jun;
Affiliation
Charles River Laboratories Germany GmbH, Max-Planck-Straße 15 A, 40699 Erkrath, Germany;
Herbrand, Ulrike;
Affiliation
National Measurement Laboratory Hosted at LGC Limited, Queens Road, Teddington TN1 10LY, UK
Huggett, Jim F.;
ORCID
0000-0002-4309-1489
Affiliation
Medicines and Healthcare Products Regulatory Agency, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK
Kempster, Sarah;
ORCID
0000-0002-8934-3389
Affiliation
National Physical Laboratory, Hampton Road, Teddington TW11 0LW, UK
Kepiro, Ibolya E.;
Affiliation
Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
Khan, Arifa S.;
ORCID
0000-0001-5460-3913
Affiliation
National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899, USA(H.-J.H.);
Kwee, Edward;
Affiliation
Cell and Gene Therapy Catapult, 12th Floor Tower Wing, Guy’s Hospital, Great Maze Pond, London SE1 9RT, UK
Li, Wilson;
Affiliation
National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899, USA(H.-J.H.);
Lin-Gibson, Sheng;
Affiliation
National Measurement Laboratory Hosted at LGC Limited, Queens Road, Teddington TN1 10LY, UK
Luckau, Luise;
ORCID
0000-0002-8092-251X
Affiliation
National Physical Laboratory, Hampton Road, Teddington TW11 0LW, UK
Minelli, Caterina;
ORCID
0000-0003-4847-1154
Affiliation
National Physical Laboratory, Hampton Road, Teddington TW11 0LW, UK
Ryadnov, Maxim G.;
Affiliation
Oxford Biomedica (UK) Ltd., Windrush Court, Transport Way, Oxford OX4 6LT, UK
Searing, Isobel;
ORCID
0000-0003-2456-898X
Affiliation
National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899, USA(H.-J.H.);
Wang, Lili;
ORCID
0000-0002-6240-6642
Affiliation
National Measurement Laboratory Hosted at LGC Limited, Queens Road, Teddington TN1 10LY, UK
Whale, Alexandra S.;
Affiliation
National Measurement Laboratory Hosted at LGC Limited, Queens Road, Teddington TN1 10LY, UK
Braybrook, Julian H.

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.

Biologics

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