Taking advantage of a high-throughput flow cytometer for the implementation of an ADCC assay for regulatory compliance

• Published in: Biotechnology reports (Amsterdam, Netherlands) Vol. 26; p. e00456
• Main Authors: Camacho-Sandoval, Rosa, Jiménez-Uribe, Alexis, Tenorio-Calvo, Alejandra V., López-Morales, Carlos A., Muñoz-García, Leslie, Montes-Luna, Alejandra, García-Xolalpa, Héctor Leonardo, Velasco-Velázquez, Marco, Pavón, Lenin, Pérez-Tapia, Sonia Mayra, Medina-Rivero, Emilio
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01-06-2020; Elsevier
• Subjects: ADCC; High-throughput flow cytometry; Short Communication; Validation bioassay; High-throughput flow cytometry; ADCC; Validation bioassay
• ISSN: 2215-017X; 2215-017X
• DOI: 10.1016/j.btre.2020.e00456

•High-throughput flow cytometry for the evaluation of ADCC potency.•Optimization of biological assays for batch release testing of biopharmaceuticals.•Quickly turn multi-parameter acquisition by flow cytometry.
Technological advances allowed the development of high-throughput instruments such as IntelliCyt iQue Screener PLUS®. Here, we took advantage of this technology to transfer a previously validated cytotoxicity assay. The evaluated parameters were cell permeability, caspase activation and phosphatidyl serine exposure. The assay was accurate (r2 = 0.90), precise (%CV ≤ 18.90) and specific. These results showed that this technology is suitable to be used in control quality environments. In addition, the automation provided a faster acquisition and analysis of data with precise and accurate results. This application could be implemented to evaluate another in vitro mechanism of action of different biotherapeutics.