BS ISO 23033:2021 Biotechnology. Analytical methods. General requirements and considerations for the testing and characterization of cellular therapeutic products

Standard Number: BS ISO 23033:2021

Pages: 44

Released: 2021-10-29

ISBN: 978 0 580 52192 8

Status: Standard

Overview

The BS ISO 23033:2021 standard is a comprehensive guide that outlines the general requirements and considerations for the testing and characterization of cellular therapeutic products. This standard is essential for professionals in the biotechnology field who are involved in the development, testing, and quality assurance of cellular therapies.

Why Choose BS ISO 23033:2021?

Cellular therapeutic products are at the forefront of modern medicine, offering groundbreaking treatments for a variety of conditions. Ensuring the safety, efficacy, and quality of these products is paramount. The BS ISO 23033:2021 standard provides a robust framework for achieving these goals, making it an indispensable resource for laboratories, research institutions, and biotech companies.

Key Features

• Comprehensive Guidelines: The standard covers all aspects of testing and characterization, from initial development to final quality assurance.
• Up-to-Date Information: Released on October 29, 2021, this standard incorporates the latest advancements and best practices in the field.
• International Recognition: As an ISO standard, it is recognized and respected globally, ensuring that your processes meet international benchmarks.
• Detailed Documentation: With 44 pages of in-depth information, this standard provides detailed guidance on every aspect of cellular therapeutic product testing.

Who Should Use This Standard?

The BS ISO 23033:2021 standard is designed for a wide range of professionals in the biotechnology sector, including:

• Research Scientists
• Quality Assurance Managers
• Regulatory Affairs Specialists
• Laboratory Technicians
• Biotech Company Executives

Applications

This standard is applicable to various stages of cellular therapeutic product development, including:

• Research and Development: Provides guidelines for initial testing and characterization of new cellular therapies.
• Clinical Trials: Ensures that products meet safety and efficacy standards before human trials.
• Manufacturing: Offers quality control measures to maintain product consistency and safety.
• Regulatory Compliance: Helps meet the stringent requirements of regulatory bodies worldwide.

Benefits

Adopting the BS ISO 23033:2021 standard offers numerous benefits, including:

• Enhanced Quality: Ensures that your cellular therapeutic products meet the highest quality standards.
• Regulatory Approval: Facilitates smoother approval processes with regulatory bodies.
• Global Acceptance: As an internationally recognized standard, it enhances the credibility and marketability of your products.
• Risk Mitigation: Reduces the risk of product recalls and adverse events by ensuring thorough testing and characterization.

Conclusion

The BS ISO 23033:2021 standard is an essential resource for anyone involved in the development and testing of cellular therapeutic products. With its comprehensive guidelines and international recognition, it provides a solid foundation for ensuring the safety, efficacy, and quality of these innovative treatments. Whether you are a research scientist, quality assurance manager, or regulatory affairs specialist, this standard will help you achieve excellence in your work.

BS ISO 23033:2021

This standard BS ISO 23033:2021 Biotechnology. Analytical methods. General requirements and considerations for the testing and characterization of cellular therapeutic products is classified in these ICS categories:

• 07.080 Biology. Botany. Zoology

This document provides general requirements for the testing of cellular therapeutic products intended for human use.

This document also provides considerations for the characterization of cellular therapeutic products, including approaches to select and design analytical methods that are fit for purpose.

Such considerations can be used to establish critical quality attributes for a cellular therapeutic product.

This document is applicable to cellular starting materials (including those for tissue engineered products) and intermediates of cellular therapeutic products.

This document is not applicable to tissues used in transplantation.