Search results for: Lot-to-lot stability of antibody reagents for flow cytometry.
#34009005 
2021/05/19
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Lot-to-lot reproducibility, stability and life cycle management of antibody reagents for flow cytometry.
The increasing number of biopharmaceuticals, gene and cell therapies in development has seen a growing use of flow cytometry to measure biomarkers, generate pharmacokinetic data, assess immunogenicity and investigate target engagement. The importance of these data types and their inclusion in regulatory submissions mean that flow cytometry analyses are now expected to demonstrate robust performance and comply with both regulatory and scientific recommendations during their validation and subsequent use in sample analysis. The control of the 'critical reagents' commonly used in flow cytometry presents some specific challenges, particularly when an assay is required for use over a long period of time across different phases of a drug development program, or where it is deployed in complex, multisite clinical studies. This paper highlights some key challenges in flow cytometry reagent management with some of the strategies employed to control and monitor flow cytometry critical reagents.David F Lanham
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#28365329 2017/03/30
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Lot-to-lot stability of antibody reagents for flow cytometry.
The fluorescence detected using fluorochrome-labelled monoclonal antibodies depends not only on the abundance of the target antigen, but amongst many other factors also on the effective fluorochrome-to-antibody ratio. The diagnostic approach of the EuroFlow consortium relies on reproducible fluorescence intensities over time. A capture bead system for mouse immunoglobulin light chains was utilized to compare the mean fluorescence intensity of 1323 consecutive antibody lots to the currently used lot of the same monoclonal antibody. In total, 157 different monoclonal antibodies were assessed over seven years. Median relative difference between consecutive lots was 3.8% (range: 0.01% to 164.7%, interquartile range: 1.3% to 10.1%). The relative difference exceeded 20% in 8.8% of all comparisons. FITC labelled monoclonal antibodies (median relative difference: 2.1%) showed a significantly smaller variation between lots than antibodies conjugated to PE (3.5%), PECy7 (3.9%), PerCPCy5.5 (5.8%), APC (5.8%), APCH7 (7.4%), and APCC750 (14.5%). Reagents labelled with Pacific Blue (1.4%), Pacific Orange (2.4%), HV450 (0.7%), and HV500 (1.7%) demonstrated more consistent results compared to conjugates of BV421 (4.1%) and BV510 (16.2%). Additionally, significant differences in lot-to-lot fluorescence stability amongst antibodies labelled with the same fluorochrome were observed between manufacturers. These observations might guide future quality recommendations for the production and application of fluorescence-labelled monoclonal antibodies in multicolor flow cytometry.Sebastian Böttcher, Vincent H J van der Velden, Neus Villamor, Matthias Ritgen, Juan Flores-Montero, Hugo Murua Escobar, Tomas Kalina, Monika Brüggemann, Georgiana Grigore, Marta Martin-Ayuso, Quentin Lecrevisse, Carlos E Pedreira, Jacques J M van Dongen, Alberto Orfao