BS ISO 21709:2020+A1:2021 Biotechnology. Biobanking. Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines

Standard number: BS ISO 21709:2020+A1:2021

Pages: 26

Released: 2021-09-28

ISBN: 978 0 539 16715 3

Name: Biotechnology. Biobanking. Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines

Status: Standard

Overview

In the rapidly evolving field of biotechnology, maintaining the highest standards of quality and process management is crucial. The BS ISO 21709:2020+A1:2021 standard provides comprehensive guidelines for the establishment, maintenance, and characterization of mammalian cell lines. This standard is essential for biobanking facilities, research institutions, and biotechnology companies that aim to ensure the integrity and reproducibility of their cell line-based research and applications.

Key Features

• Comprehensive Guidelines: This standard offers detailed instructions on the processes and quality requirements necessary for the successful establishment and maintenance of mammalian cell lines.
• Quality Assurance: Ensures that all procedures meet the highest quality standards, thereby enhancing the reliability and reproducibility of research outcomes.
• Characterization Protocols: Provides specific protocols for the characterization of cell lines, ensuring that they meet the required specifications for various applications.
• Updated Information: The 2021 amendment (A1:2021) includes the latest updates and improvements, making this standard current and highly relevant.

Why This Standard is Important

The BS ISO 21709:2020+A1:2021 standard is a critical resource for anyone involved in the field of biotechnology and biobanking. Here are some reasons why this standard is indispensable:

• Ensures Consistency: By following the guidelines set forth in this standard, organizations can ensure that their cell lines are consistent and reliable, which is crucial for reproducible research.
• Enhances Credibility: Adhering to internationally recognized standards enhances the credibility of your research and can facilitate collaborations with other institutions and companies.
• Regulatory Compliance: Many regulatory bodies require compliance with specific standards. This standard helps organizations meet those requirements, thereby avoiding potential legal and regulatory issues.
• Improves Efficiency: Clear guidelines and protocols can streamline processes, reducing the time and resources needed to establish and maintain cell lines.

Who Should Use This Standard?

This standard is designed for a wide range of professionals and organizations, including:

• Biobanking Facilities: Ensure the highest quality and consistency in the storage and maintenance of cell lines.
• Research Institutions: Enhance the reliability and reproducibility of research outcomes by adhering to standardized protocols.
• Biotechnology Companies: Improve product development processes and ensure compliance with regulatory requirements.
• Quality Assurance Teams: Implement robust quality control measures to maintain the integrity of cell lines.

Detailed Content

The BS ISO 21709:2020+A1:2021 standard is divided into several sections, each focusing on a specific aspect of cell line management:

• Introduction: Provides an overview of the standard and its objectives.
• Scope: Defines the scope of the standard and the types of cell lines it covers.
• Normative References: Lists the documents and standards referenced in the text.
• Terms and Definitions: Clarifies the terminology used in the standard.
• Establishment of Cell Lines: Outlines the procedures for the initial establishment of cell lines, including sourcing, isolation, and initial characterization.
• Maintenance of Cell Lines: Provides guidelines for the ongoing maintenance and monitoring of cell lines to ensure their stability and integrity.
• Characterization of Cell Lines: Details the protocols for the thorough characterization of cell lines, including genetic, phenotypic, and functional analyses.
• Quality Control: Describes the quality control measures that should be implemented to ensure the reliability and reproducibility of cell lines.
• Documentation and Reporting: Emphasizes the importance of thorough documentation and reporting to maintain transparency and traceability.

Conclusion

The BS ISO 21709:2020+A1:2021 standard is an invaluable resource for anyone involved in the field of biotechnology and biobanking. By providing comprehensive guidelines and protocols, this standard ensures the highest levels of quality and consistency in the establishment, maintenance, and characterization of mammalian cell lines. Whether you are a researcher, a quality assurance professional, or a biotechnology company, adhering to this standard will enhance the credibility and reliability of your work, facilitating successful outcomes and collaborations.

BS ISO 21709:2020+A1:2021

This standard BS ISO 21709:2020+A1:2021 Biotechnology. Biobanking. Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines is classified in these ICS categories:

• 07.080 Biology. Botany. Zoology

This document specifies process and quality requirements for the biobanking of mammalian (including human) cell lines. It describes requirements for the fundamental procedures of the biobank handling cell lines, such as establishment, reception, identification, propagation, preservation, storage, quality control, and distribution of cell lines.

This document can be used by organizations performing biobanking activities with mammalian cell lines used for research and development, biobank users, organizations and schemes using peer-assessment and accreditation bodies.

This document does not apply to biological material intended for therapeutic use.

NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.