Compliance-Ready Flow Cytometry with the ZE5 Cell Analyzer

01 February, 2023
Compliance-Ready Flow Cytometry with the ZE5 Cell Analyzer

The value of flow cytometry in drug discovery is increasingly recognized due to its ability to provide highly granular, multiparameter data. High-throughput, high-parameter instruments such as the ZE5 Cell Analyzer have led the way as essential tools for activities like target identification and lead discovery. However, drug discovery is a highly regulated industry and once the drug discovery process progresses into an environment that requires FDA compliance, the choice of instruments that meet the required standard can become limited. At Bio-Rad, we recognize the need for cutting-edge flow cytometry at all stages of the drug discovery process, so we have partnered with Xybion to provide a solution for compliance-ready flow cytometry with the ZE5 Cell Analyzer. 

Why Is FDA 21 CFR Part 11 Compliance Important?

United States Food and Drug Administration (FDA) Title 21 Code of Federal Regulations (CFR) Part 11 states that electronic records can be regarded at the same level as handwritten signatures if they adhere to the requirements specified. Electronic systems that support Part 11 ensure the integrity, confidentiality, and authenticity of raw data collected and stored electronically. Although current good manufacturing practice (cGMP) does not require the use of software for the submission of documents or signatures, the use of 21 CFR Part 11 compliant software is widely used in organizations regulated by the FDA in the United States, or in those that are regulated under EU Annex 11 in the European Union, such as pharma, biotech, contract research, and contract manufacturing organizations.

Why Is the ZE5 Cell Analyzer a Good Fit for a Regulated Environment?

The ZE5 Cell Analyzer represents the ideal combination of high-parameter and high-throughput flow cytometry needed for drug discovery. It is able to handle complex assays with up to 30 parameters and five lasers, and offers superior speed — it can power through a 96-well plate in <15 minutes, acquiring tens of thousands of events per well. Crucially, its platform-agnostic application programming interface supports integration into any robotic work cell, making it the ideal choice for highly automated environments. Adding the ZE5 Cell Analyzer to any stage of a drug discovery workflow that necessitates high sample throughput can lead to a step change in productivity, breaking the bottleneck of slow data acquisition.

Who Is Xybion?Xybion Logo

Xybion is a global software and services company that helps enterprise life sciences organizations accelerate new drug development into approved medicines. Xybion digitizes drug research and development, laboratory testing, regulatory approvals, and pharmaceutical manufacturing on a single, unified cloud platform that is cost-effective, ready to deploy, and easy to use. Xybion has over 160 clients in 29 countries using its low-code software to accelerate speed of innovation, improve compliance, expand capacity, minimize operating risks, and reduce expenses while keeping employees safe. These modules are unified, creating a robust lab execution system that provides a seamless experience for all laboratory staff and a very simple IT ecosystem to maintain for the IT organization.

How Does Xybion’s Compliance Builder Support Compliance?

Xybion’s CQRM XD Compliance Builder provides 21 CFR Part 11 compliance support with minimal system and operator changes. It provides a secure and independent audit trail, which includes date and time stamps, by recording all actions pertaining to the data being secured as well as the identification of the user who initiated the action. Because the audit trail is captured as data events happen, this serves as evidence of the time that raw data are created. It also records evidence of subsequent data events, such as addition, deletion, and modification, ensuring data integrity and transparency. Electronic signatures can also be captured for all data events, helping to eliminate the need to print and maintain paper records with wet signatures.

Want to Find Out More About Compliance-Ready Flow Cytometry?

Bio-Rad is committed to bringing you the tools you need to accelerate your drug discovery workflow. Our experts are ready to speak with you about how the ZE5 Cell Analyzer can bring cutting-edge flow cytometry to your laboratory, or to discuss FDA 21 CFR Part 11 compliance support for flow cytometry applications.



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