Article: Connecting Cryopreserved Therapies to Patients

By Volker Kirchner |

Cryogenic shipping is increasingly favoured by therapy developers. Here’s why rigorous quality standards and detailed cleaning regimens are required to enable a robust cryogenic supply chain.

One in four cell and gene therapy (CGT) shipments are now cryopreserved[1] - Fig 1. Therapy developers are increasingly manufacturing cryopreserved therapies as this removes the issue of shelf life and builds flexibility into the supply chain. 

The cryogenic shipping process

 

(Fig 1)

To help therapy developers understand what is required to manage cryogenic shipping, this article provides insight into the rigorous quality standards and detailed cleaning regimens that need to be in place, on a global scale, to enable a robust cryogenic supply chain.

Cryopreserved shipments are executed within cryo-shippers, sometimes called dry-shippers or dewars, which use traditionally use absorbed liquid nitrogen (LN2) to maintain temperatures of as low as -196⁰C. At these temperatures, all cellular activity stops, meaning donations and therapies are not restricted by the short shelf lives that constrain “fresh” shipments made at warmer temperatures (generally 2-8⁰C which must be delivered, often, within 24 hours).

Cryo-logistics platform

To support therapy developers, World Courier has partnerships with SAVSU[2] , CryoPort[3] , and our own cryogenic shippers, creating a fleet of more than 300 cryo-shippers[4] , as well as the ability to transport clients own cryo-shippers.

Regardless of the cryo-shipper model, the overarching quality system is the same. A number of key principles govern the receipt through to return-to-service for a shipper in the World Courier network:

  • Traceability: Actions are recorded with user, time and date recorded
  • Training: Only associates who have been trained on specific dry shipper SOPs can execute key steps in the receipt and return-to-service process
  • Thoroughness: Cryo-shippers are cleaned, inspected and charged according to SOPs to ensure they are ready for use

Overall, these quality system principles translate to six blocks of activity. Figure 2 shows the receipt and return-to-service process flow for SAVSU units as an example. 

The importance of a robust quality system

 

Fig 2 – Receipt through return-to-service for SAVSU units

World Courier’s track record

Executing more than 12,000 cryo-shipments every year, the first of which was in the early 1990s, World Courier is a logistics platform developer focused on time-sensitive and temperature-critical shipments. With a team focused on advanced therapies we are the only specialty logistics provider with Good Distribution Practice (GDP) accreditation throughout its global network. We have experience of building robust cryogenic supply chains with global-scale quality standards and detailed cleaning regimens.

This article has focused on cryo-shipping, however this level of activity is echoed for all shipping systems, regardless of temperature or design. This is vital as the industry grows since it will be robust quality systems, within logistics companies, that form the link in the quality chain between GMP and GCP[5]. This enables patients to be connected to therapies at clinical and commercial scale.

I hope that this information has been useful but if you would like to know more, please let me know or arrange to audit any of the 140+ offices within our global network[6].

[1] Internal World Courier data
[2] SAVSU press release Jan 28th, 2018
[3] CryoPort press release July 17th, 2018
[4] We manage a fleet comprising SAVSU, MVE, Taylor-Wharton and Air Liquide units
[5] GMP = Good Manufacturing Practice, GCP = Good Clinical Practice
[6] https://www.worldcourier.com/contact-us-home/locations


About the Author

A portrait of Volker Kirchner.

Volker Kirchner

Director, Temperature Control Solutions
World Courier
Volker Kirchner is Director of Temperature Control Solutions for World Courier, where he is responsible for all matters pertaining to temperature control solutions, packaging, qualification and packaging distribution and return logistics for World Courier's more than 140 offices in 50+ countries worldwide. He brings deep expertise in temperature-controlled transport, logistics and packaging. Since 2001, Volker has served in a number of roles with increasing strategic responsibility at World Courier, including operations management, CSC and service development.
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