BS ISO 21973:2020 - Biotechnology: General Requirements for Transportation of Cells for Therapeutic Use

In the rapidly evolving field of biotechnology, the transportation of cells for therapeutic use is a critical component that demands precision, safety, and adherence to stringent standards. The BS ISO 21973:2020 standard provides comprehensive guidelines to ensure that these vital biological materials are transported under conditions that maintain their integrity and efficacy.

Overview of BS ISO 21973:2020

Released on July 21, 2020, this standard is a pivotal document for professionals involved in the biotechnology sector, particularly those handling the transportation of therapeutic cells. With 28 pages of detailed requirements, it serves as an essential resource for ensuring compliance with international best practices.

Key Features and Benefits

• Comprehensive Guidelines: The standard outlines the general requirements necessary for the safe and effective transportation of cells intended for therapeutic use, ensuring that they reach their destination in optimal condition.
• International Recognition: As an ISO standard, it is recognized globally, facilitating international collaboration and trade in the biotechnology sector.
• Quality Assurance: Adhering to this standard helps organizations demonstrate their commitment to quality and safety, which is crucial in the highly regulated field of biotechnology.
• Risk Management: The standard provides a framework for identifying and mitigating risks associated with the transportation of therapeutic cells, thereby enhancing the reliability of biotechnological processes.

Who Should Use This Standard?

The BS ISO 21973:2020 standard is indispensable for a wide range of stakeholders in the biotechnology industry, including:

• Biotechnology Companies: Organizations involved in the development and commercialization of cell-based therapies will find this standard crucial for ensuring the safe transport of their products.
• Logistics Providers: Companies specializing in the transportation of biological materials can use this standard to enhance their service offerings and ensure compliance with industry regulations.
• Regulatory Bodies: Government and regulatory agencies can reference this standard to develop and enforce policies related to the transportation of therapeutic cells.
• Research Institutions: Academic and research institutions involved in cell therapy research can utilize this standard to ensure the integrity of their samples during transportation.

Technical Specifications

The BS ISO 21973:2020 standard is identified by the Standard Number: BS ISO 21973:2020 and is available under the ISBN 978 0 580 97166 2. It is currently in the status of a Standard, reflecting its acceptance and implementation across the industry.

Why Adhere to BS ISO 21973:2020?

Compliance with the BS ISO 21973:2020 standard is not just about meeting regulatory requirements; it is about ensuring the highest level of care and precision in the transportation of therapeutic cells. This adherence can lead to:

• Enhanced Patient Safety: By ensuring that therapeutic cells are transported under optimal conditions, the standard helps protect patient safety and treatment efficacy.
• Increased Market Access: Organizations that comply with international standards like BS ISO 21973:2020 are better positioned to access global markets and collaborate with international partners.
• Reputation and Trust: Demonstrating compliance with this standard can enhance an organization's reputation and build trust with stakeholders, including patients, healthcare providers, and regulatory bodies.

Conclusion

The BS ISO 21973:2020 standard is a cornerstone document for the biotechnology industry, providing essential guidelines for the transportation of cells for therapeutic use. Its comprehensive approach to quality assurance, risk management, and international compliance makes it an invaluable resource for any organization involved in the handling and transportation of these critical biological materials.

By adhering to this standard, organizations can ensure the safe and effective delivery of cell-based therapies, ultimately contributing to the advancement of medical science and the improvement of patient outcomes worldwide.

BS ISO 21973:2020

This standard BS ISO 21973:2020 Biotechnology. General requirements for transportation of cells for therapeutic use is classified in these ICS categories:

• 07.080 Biology. Botany. Zoology

This document specifies general requirements and reviews the points to consider for the transportation of cells for therapeutic use, including storage during transportation.

Transportation starts from the transfer of the packaged cells by the sender to the transportation service provider and ends when the package is delivered to the receiver at its destination.

This document does not apply to transportation of cells within one facility.

This document includes the development of a transportation plan including verification and validation, communication between the client and the transportation service provider, and associated documentation.

This document does not specify particular conditions for transportation such as specification for shipping container, ambient temperature control, etc.