Biologics (May 2024)
Standards and Metrology for Viral Vectors as Molecular Tools: Outcomes from a CCQM Workshop
- Jonathan J. Campbell,
- Neil Almond,
- Young-Kyong Bae,
- Ravneet Bhuller,
- Andrea Briones,
- Sang-Joon Cho,
- Megan H. Cleveland,
- Thomas E. Cleveland,
- Francis Galaway,
- Hua-Jun He,
- Ulrike Herbrand,
- Jim F. Huggett,
- Sarah Kempster,
- Ibolya E. Kepiro,
- Arifa S. Khan,
- Edward Kwee,
- Wilson Li,
- Sheng Lin-Gibson,
- Luise Luckau,
- Caterina Minelli,
- Maxim G. Ryadnov,
- Isobel Searing,
- Lili Wang,
- Alexandra S. Whale,
- Julian H. Braybrook
Affiliations
- Jonathan J. Campbell
- National Measurement Laboratory Hosted at LGC Limited, Queens Road, Teddington TN1 10LY, UK
- Neil Almond
- Medicines and Healthcare Products Regulatory Agency, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK
- Young-Kyong Bae
- Korea Research Institute of Standards and Science, 267 Gajeong-Ro, Yuseong-Gu, Daejeon 34113, Republic of Korea
- Ravneet Bhuller
- Medicines and Healthcare Products Regulatory Agency, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK
- Andrea Briones
- National Physical Laboratory, Hampton Road, Teddington TW11 0LW, UK
- Sang-Joon Cho
- Park Systems Corp., 109, Gwanggyo-ro, Yeongtong-gu, Suwon-si 16229, Republic of Korea
- Megan H. Cleveland
- National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899, USA
- Thomas E. Cleveland
- National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899, USA
- Francis Galaway
- Medicines and Healthcare Products Regulatory Agency, 10 South Colonnade, Canary Wharf, London E14 4PU, UK
- Hua-Jun He
- National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899, USA
- Ulrike Herbrand
- Charles River Laboratories Germany GmbH, Max-Planck-Straße 15 A, 40699 Erkrath, Germany
- Jim F. Huggett
- National Measurement Laboratory Hosted at LGC Limited, Queens Road, Teddington TN1 10LY, UK
- Sarah Kempster
- Medicines and Healthcare Products Regulatory Agency, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK
- Ibolya E. Kepiro
- National Physical Laboratory, Hampton Road, Teddington TW11 0LW, UK
- Arifa S. Khan
- Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
- Edward Kwee
- National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899, USA
- Wilson Li
- Cell and Gene Therapy Catapult, 12th Floor Tower Wing, Guy’s Hospital, Great Maze Pond, London SE1 9RT, UK
- Sheng Lin-Gibson
- National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899, USA
- Luise Luckau
- National Measurement Laboratory Hosted at LGC Limited, Queens Road, Teddington TN1 10LY, UK
- Caterina Minelli
- National Physical Laboratory, Hampton Road, Teddington TW11 0LW, UK
- Maxim G. Ryadnov
- National Physical Laboratory, Hampton Road, Teddington TW11 0LW, UK
- Isobel Searing
- Oxford Biomedica (UK) Ltd., Windrush Court, Transport Way, Oxford OX4 6LT, UK
- Lili Wang
- National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899, USA
- Alexandra S. Whale
- National Measurement Laboratory Hosted at LGC Limited, Queens Road, Teddington TN1 10LY, UK
- Julian H. Braybrook
- National Measurement Laboratory Hosted at LGC Limited, Queens Road, Teddington TN1 10LY, UK
- DOI
- https://doi.org/10.3390/biologics4020013
- Journal volume & issue
-
Vol. 4,
no. 2
pp. 187 – 201
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
