PD ISO/TS 22859-1:2022 Biotechnology. Biobanking. Requirements for human mesenchymal stromal cells derived from umbilical cord tissue

Standard number: PD ISO/TS 22859-1:2022

Pages: 44

Released: 2022-08-23

ISBN: 978 0 539 01798 4

Name: Biotechnology. Biobanking. Requirements for human mesenchymal stromal cells derived from umbilical cord tissue

Status: Standard

Overview

In the rapidly evolving field of biotechnology, the importance of standardized protocols cannot be overstated. The PD ISO/TS 22859-1:2022 is a comprehensive standard that sets forth the requirements for biobanking human mesenchymal stromal cells (MSCs) derived from umbilical cord tissue. This document is essential for researchers, biobank managers, and healthcare professionals who are involved in the collection, processing, and storage of these valuable cells.

Why This Standard is Essential

Human mesenchymal stromal cells (MSCs) derived from umbilical cord tissue have shown immense potential in regenerative medicine, tissue engineering, and various therapeutic applications. However, the efficacy and safety of these cells are highly dependent on the quality of the biobanking process. The PD ISO/TS 22859-1:2022 standard provides a robust framework to ensure that MSCs are collected, processed, and stored under optimal conditions, thereby maintaining their viability and functionality.

Key Features

• Comprehensive Guidelines: The standard offers detailed guidelines on the entire biobanking process, from the initial collection of umbilical cord tissue to the final storage of MSCs.
• Quality Assurance: It includes stringent quality control measures to ensure the integrity and purity of the stored cells.
• Safety Protocols: The document outlines safety protocols to minimize the risk of contamination and ensure the safety of both the cells and the personnel handling them.
• Regulatory Compliance: Adhering to this standard helps organizations comply with national and international regulations, thereby facilitating smoother collaborations and research initiatives.

Detailed Content

The PD ISO/TS 22859-1:2022 standard spans 44 pages and covers a wide range of topics, including:

• Collection Procedures: Best practices for the collection of umbilical cord tissue to ensure the highest quality of MSCs.
• Processing Techniques: Detailed protocols for the isolation and processing of MSCs to maintain their viability and functionality.
• Storage Conditions: Guidelines for the optimal storage conditions to preserve the integrity of the cells over long periods.
• Quality Control: Methods for assessing the quality and purity of the stored MSCs.
• Documentation: Requirements for thorough documentation to ensure traceability and accountability.

Who Should Use This Standard?

This standard is indispensable for a wide range of professionals, including:

• Researchers: Scientists involved in stem cell research and regenerative medicine will find this standard invaluable for ensuring the quality of their cell samples.
• Biobank Managers: Those responsible for the operation of biobanks will benefit from the comprehensive guidelines and quality control measures outlined in this document.
• Healthcare Professionals: Medical practitioners involved in therapeutic applications of MSCs can rely on this standard to ensure the safety and efficacy of the cells they use.
• Regulatory Bodies: Organizations responsible for overseeing biobanking activities will find this standard useful for setting benchmarks and ensuring compliance.

Benefits of Adopting This Standard

Adopting the PD ISO/TS 22859-1:2022 standard offers numerous benefits, including:

• Enhanced Quality: Ensures the highest quality of MSCs, thereby improving the outcomes of research and therapeutic applications.
• Increased Safety: Minimizes the risk of contamination and ensures the safety of both the cells and the personnel handling them.
• Regulatory Compliance: Helps organizations comply with national and international regulations, facilitating smoother collaborations and research initiatives.
• Operational Efficiency: Streamlines the biobanking process, making it more efficient and cost-effective.
• Global Recognition: Adhering to an internationally recognized standard enhances the credibility and reputation of the organization.

Conclusion

In conclusion, the PD ISO/TS 22859-1:2022 standard is an essential resource for anyone involved in the biobanking of human mesenchymal stromal cells derived from umbilical cord tissue. Its comprehensive guidelines, stringent quality control measures, and safety protocols ensure the highest quality and safety of the stored cells. By adopting this standard, organizations can enhance their operational efficiency, comply with regulatory requirements, and contribute to the advancement of regenerative medicine and therapeutic applications.

PD ISO/TS 22859-1:2022

This standard PD ISO/TS 22859-1:2022 Biotechnology. Biobanking. Requirements for human mesenchymal stromal cells derived from umbilical cord tissue is classified in these ICS categories:

• 07.080 Biology. Botany. Zoology