What The New ISO 21973 Guidance Means For Cell And Gene Therapy Developers

By By Rob Jones, Vice President of Global BioServices

You may have heard about the release of ISO 21973:2020, but are wondering what it means. Our experts are here to break it down for you.

Pharmaceutical companies are required to comply with stringent national and international standards, regulations, and laws when developing and manufacturing their products. However, transportation companies are not required to comply with those same rules, putting the product at, potentially, significant risk.

ISO 21973:2020, titled “General Requirements for Transportation of Cells for Therapeutic Use,” is a significant step forward in ensuring that these life-saving and life-changing therapies are always transported consistently, with an emphasis on compliance, validation, decontamination, traceability, and quality management.