What the New ISO 21973 Guidance Means for Animal Biotech

Mar 5, 2021 10:24:11 AM | By Tony Thomas, Executive Director - Business Development, Animal Health

A new regulatory guidance for the safe transportation of cell and gene therapies is also important for animal health therapies. Here, we break down ISO 21973 and how it relates to shipping requirements for stem cell therapies, as well as animal embryos and gametes (eggs and sperm), and the steps Cryoport has taken to ensure compliance. Firstly, what is ISO? 

The International Organization for Standardization is made up of nearly 800 technical committees. It has published over 23,000 standards covering all aspects of technology and manufacturing.  

What is so significant about ISO 21973:2020 for animal health? 

ISO 21973 is the first standard to address the specific risks of transporting cellular material for therapeutic use. Although this new guidance is directed at the human biotechnology industry, we foresee that it indicates requirements to come for animal stem cell therapies and reproductive medicine, including documentation for all stages of transportation (i.e storage and handling, chain of custody and chain of condition) and other critical steps that are often overlooked. Mitigating risk has long been Cryoport’s paramount concern, and we have purposefully structured our quality management and processes to provide the safest possible shipping environment and journey for your medical materials.  

Who developed ISO 21973:2020? 

ISO 21973 has taken several years from initial concept to final publication, and has involved major organizations such as the FDA, NIST, the Alliance for Regenerative Medicine as well as industry key opinion leaders from industry and academia. Cryoport is proud to have been involved as an industry leader in the development of ISO 21973 and, as you read through the standard, you will see many references to our standard processes:  

ISO 21973 Requirement: 

  • Traceability 
  • Segregation of Human- vs. Animal-derived products  
  • Cleaning & Decontamination  
  • Validation, Verification and Qualification 
  • Chain of Custody & Tracking 

How Cryoport Meets the Requirement: 

   

Our involvement in defining the standard has ensured that we meet the requirements of ISO 21973, which is something that many transportation organizations cannot claim.  

So is Cryoport ISO 21973:2020 compliant?  

Not yet. When there is an accredited body capable of performing the audit for ISO 21973:2020, we are confident we will achieve inspectional success.   

Has Cryoport achieved any other ISO accreditations?  

Yes. We recently achieved ISO 9001:2015 accreditation, which evaluates the strength of an organization’s quality management system and associated processes. It assesses if all processes and systems are sufficiently robust, sustainable, and adhered to by employees at all levels of the organization. With the ISO 9001:2015 certification, Cryoport can provide a third party’s validation of our exceptional level of quality and organizational discipline.  

 

Tony Thomas

 

Tony Thomas is the Executive Director - Business Development, Animal Health for Cryoport Systems. He grew up on a family farm and followed those interests through his academic career. He has over 20 years of professional experience in the global animal agriculture industry with particular focus on genetics and animal health. Tony and his family live near Nashville, Tennessee.

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