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

by Cleveland, Thomas E. , Huggett, Jim F. , Khan, Arifa S. , Briones, Andrea , Searing, Isobel , Bae, Young-Kyong , Whale, Alexandra S. , Herbrand, Ulrike , Kwee, Edward , Bhuller, Ravneet , Braybrook, Julian H. , Li, Wilson , Almond, Neil , Lin-Gibson, Sheng , Kepiro, Ibolya E. , Minelli, Caterina , Cleveland, Megan H. , Kempster, Sarah , Galaway, Francis , He, Hua-Jun , Wang, Lili , Cho, Sang-Joon , Campbell, Jonathan J. , Ryadnov, Maxim G. , Luckau, Luise

in analytical methods / Biotechnology / characterisation / Clinical trials / Drug dosages / Expression vectors / Gene therapy / Gene transfer / Laboratories / Manufacturing / measurement / metrology / Process controls / R&D / Reagents / Reference materials / Research & development / Vectors (Biology) / viral vectors / Viruses

2024

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

2024

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

2024

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Journal Article

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

Cleveland, Thomas E.,

Huggett, Jim F.,

Khan, Arifa S.,

Briones, Andrea,

Searing, Isobel,

Bae, Young-Kyong,

Whale, Alexandra S.,

Herbrand, Ulrike,

Kwee, Edward,

Bhuller, Ravneet,

Braybrook, Julian H.,

Li, Wilson,

Almond, Neil,

Lin-Gibson, Sheng,

Kepiro, Ibolya E.,

Minelli, Caterina,

Cleveland, Megan H.,

Kempster, Sarah,

Galaway, Francis,

He, Hua-Jun,

Wang, Lili,

Cho, Sang-Joon,

Campbell, Jonathan J.,

Ryadnov, Maxim G.,

Luckau, Luise

2024

Overview

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.

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MDPI AG

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