BS ISO 20391-2:2019 Biotechnology: Cell Counting Experimental Design and Statistical Analysis

Unlock the potential of your biotechnological research with the BS ISO 20391-2:2019 standard. This comprehensive document is an essential resource for professionals in the field of biotechnology, providing a detailed framework for cell counting, experimental design, and statistical analysis to quantify the performance of counting methods.

Overview

The BS ISO 20391-2:2019 standard is a pivotal document that addresses the critical aspects of cell counting in biotechnology. Released on September 5, 2019, this standard is designed to enhance the accuracy and reliability of cell counting methods, which are fundamental to a wide range of biotechnological applications.

Key Features

• Standard Number: BS ISO 20391-2:2019
• Pages: 62
• ISBN: 978 0 580 94246 4
• Status: Standard

Why Choose BS ISO 20391-2:2019?

This standard is meticulously crafted to support researchers and professionals in the biotechnology sector by providing:

• Comprehensive Guidelines: Detailed instructions on experimental design and statistical analysis to ensure the precision and accuracy of cell counting methods.
• Enhanced Methodology: Strategies to improve the reliability of cell counting, which is crucial for experimental reproducibility and data integrity.
• Global Relevance: As an ISO standard, it is recognized and utilized worldwide, ensuring that your research meets international benchmarks.

Applications

The BS ISO 20391-2:2019 standard is applicable across various domains within biotechnology, including but not limited to:

• Pharmaceutical Research: Ensuring accurate cell counts in drug development and testing.
• Clinical Diagnostics: Providing reliable data for diagnostic assays and patient monitoring.
• Biomanufacturing: Supporting quality control processes in the production of biological products.

Benefits of Implementing the Standard

By integrating the BS ISO 20391-2:2019 standard into your research and development processes, you can achieve:

• Improved Data Quality: Enhanced accuracy and consistency in cell counting results.
• Increased Efficiency: Streamlined experimental design and analysis processes.
• Regulatory Compliance: Alignment with international standards, facilitating smoother regulatory approvals.

Conclusion

The BS ISO 20391-2:2019 standard is an invaluable tool for any biotechnology professional seeking to optimize their cell counting methodologies. With its comprehensive guidelines and global recognition, it is a cornerstone for achieving excellence in biotechnological research and development.

Embrace the power of standardized methodologies and elevate your research with the BS ISO 20391-2:2019 standard. Whether you are involved in pharmaceutical research, clinical diagnostics, or biomanufacturing, this standard provides the framework you need to ensure precision, reliability, and compliance in your cell counting processes.

BS ISO 20391-2:2019

This standard BS ISO 20391-2:2019 Biotechnology. Cell counting is classified in these ICS categories:

• 07.080 Biology. Botany. Zoology

This document provides a method for evaluating aspects of the quality of a cell counting measurement process for a specific cell preparation through a set of quality indicators derived from a dilution series experimental design and statistical analysis. The quality indicators are based on repeatability of the measurement and the degree to which the results conform to an ideal proportional response to dilution. This method is applicable to total, differential, direct and indirect cell counting measurement processes, provided that the measurement process meets the criteria of the experimental design (e.g. cells are suspended in a solution).

This method is most suitable during cell counting method development, optimization, validation, evaluation and/or verification of cell counting measurement processes.

This method is especially applicable in cases where an appropriate reference material to assess accuracy is not readily available. This method does not directly provide the accuracy of the cell count.

This method is primarily applicable to eukaryotic cells.