Richard Cuthbert
The differences between us are what makes life interesting, and diversity in a group that shares a common goal can lead to many benefits. Here we examine the similarities and differences between researchers using flow cytometry for academic research and those using it for drug discovery. We outline the challenges they face and learn that they share a common goal as well as a common solution.
Both society and science often seek to understand the world by dividing it into groups – groups that are often compared to or even pitted against one another. In many ways, the difference between any two groups of humans is very small, but subtle differences can have a significant impact. When we share common goals, diversity builds stronger teams and helps us to accomplish complex tasks — while one approach may be perfect for addressing one part of a problem, a different approach is more suited for another. This also applies to those using flow cytometry in academic research and those using it as part of drug discovery. Both groups use very similar tools and techniques and share a great deal of common knowledge, but the diversity of approach provides crucial advantages in each case.
Flow in Different Settings
Flow cytometry has emerged as a powerful and versatile tool in both academic research and the pharmaceutical industry. It allows for the rapid quantitative analysis of physical and chemical characteristics of cells or particles suspended in a fluid, making it indispensable for a wide range of applications, from basic research to the development and approval of new therapeutics.
However, the role of flow cytometry in drug discovery, particularly in regulated laboratories, differs significantly from its use in academic research. These differences arise from the distinct goals, regulatory requirements, and constraints in each environment. While academic labs typically prioritize hypothesis-driven exploratory research, the pharmaceutical industry focuses on clinical outcomes, precision, and regulatory compliance to bring drugs safely and effectively to market.
The primary objective in academic labs is to generate new knowledge. Because this exploratory work occurs outside the strict framework of human trials, researchers have great flexibility in their use of flow cytometry. While rigor is always critical, the absence of stringent standardization and the more relaxed recordkeeping requirements leave more room for adaptation and more time for exploration. Not only does this help speed the progress of academic research, it also empowers creativity and innovation, leading to advancements that may later be applied to the drug development sector.
In contrast, researchers working in drug development must contend with regulators enforcing strict and exacting criteria for multiple parameters. While this is neither surprising nor unwarranted given that the data generated form the basis for critical decisions regarding drug efficacy and safety, it imposes limitations that fundamentally influence the way these researchers operate.
The U.S. Food and Drug Administration (FDA) regulates drug development in the United States, with similar organizations existing in other countries. The FDA requires validation of flow cytometry assays to ensure their accuracy, precision, specificity, sensitivity, and reproducibility. Assay validation is crucial for confirming that results are reliable across different laboratories and studies. Protocols used in drug discovery must include rigorous quality control procedures including regular calibration of flow cytometers, control of sample handling, and data acquisition. Importantly, thorough documentation of every aspect of these procedures, such as the name of the operator and the date and time they are performed, is critical. The collection of this level of evidence can be time consuming.
Data Management
Maintaining the integrity and traceability of data generated by flow cytometry is also critical under FDA regulations. This includes the use of validated software for data analysis, ensuring that raw data can be audited, and establishing procedures for electronic data management that are compliant with FDA 21 CFR Part 11, which deals with electronic records and signatures. Therefore, instruments and software that support FDA 21 CFR Part 11 compliance are critical. Other regulatory authorities apply their own version of data management requirements.
In academic labs, the data generated by flow cytometry is used primarily for publications and is generally not required to meet the same standards of traceability and compliance required by the FDA. Researchers may use a variety of software platforms for data analysis, and the focus is often on innovation and exploration rather than on maintaining strict protocols for data storage, audit trails, and reproducibility.
Automation
The use of automation is another important differentiator. In drug discovery, the need to screen large numbers of drug candidates drives the adoption of high-throughput flow cytometry systems capable of analyzing large volumes of samples rapidly and with minimal variability. Automated systems integrate sample preparation, data acquisition, and analysis, reducing the likelihood of human error. Not all instruments work well with automation, so assessment of an instrument’s suitability is critical in these environments. This contrasts with academic labs, where throughput is often lower and manual operation is more common. Experiments in academic labs are more likely to involve larger numbers of markers and therefore there is a greater need for high-parameter instrumentation as well as a diverse range of fluorophores. However, the use of automated features that aid ease of use and save time can still bring great benefits in multi-user academic environments.
The ZE5 Cell Analyzer is compatible with multiple automation systems. It is shown here with the PlateCrane EX Robotic Arm Microplate Handler and SoftLinx Automation Software from Hudson Robotics.
Bridging the Gap
Combining different approaches offers clear benefits for solving complex problems. Having a single tool with features that make it flexible enough to enable multiple ways of working is a great benefit. The ZE5 Cell Analyzer is a flow cytometer that performs well in any laboratory. It combines the high-parameter analysis often needed in academic labs with the high throughput needs and FDA 21 CFR Part 11 support required in drug discovery. It has a host of features that make it ideal for automation, including automated cleaning and fault recovery, and user-friendly features like automatic fluidics management and sample monitoring that are great for environments with users of varying proficiency.
At their core, both academic and drug discovery researchers share the same goal: to understand biology and to use that understanding to prolong and improve lives. To achieve this goal, both the rigorous precision of pharma laboratories and the flexibility of academia are required. At Bio-Rad, we aim to celebrate the power of diverse approaches, find solutions that cross boundaries, and ultimately, advance science and save lives, together.
Visit our website to learn more about the ZE5 Cell Analyzer, flow cytometry in drug discovery, and Bio‑Rad’s commitment to diversity and inclusion.