Keeping Cell and Gene Therapies Alive in Transit
Industry Insight Mar 27, 2019
Proprietary and dedicated human-use-only Cryoport Express® shipper used for regenerative medicine advanced therapies. Image credit: Cryoport
Cryoport is the single largest cryogenic delivery system for immunotherapy drugs, and is the sole cryogenics logistics provider for the first two commercialized cell therapies, Novartis’ Kymriah (a gene therapy product for treating two types of blood cancer) and Kite’s Yescarta (the first CAR T therapy for non-Hodgkin lymphoma).
Cryoport came to our attention following their announcement to unveil their Global Logistics Center in Amsterdam, enabling the expansion of their global network.
To learn more about the company providing the logistics backbone of clinical trials for regenerative medicine, we caught up with Cryoport’s chief commercial officer, Mark Sawicki.
Michele Wilson (MW): Can you please outline why it is so important that biological materials are transported correctly?
Mark Sawicki (MS): Most of the cell and gene therapies today are very valuable (approximately $300k to $1 million per treatment), take weeks to manufacture, and are fragile.
In many cases, they are irreplaceable. A simple temperature variation can destroy biological materials in a matter of seconds. It is critical to protect the cells to keep them from dying or changing while in transit for efficacy and safety.
MW: Can you tell us about The SmartPak II, and explain how you use it to keep track of precious cargo?
MS: The SmartPak IITM Condition Monitoring System provides near real-time information while tracking location, temperature, orientation, humidity, and shock as well as other factors not listed.
This information is automatically collected and retained by Cryport’s cloud-based logistics management platform called the Cryoportal®.
This integrated combination enables Cryoport’s customer support team to monitor and track every shipment globally and give them the ability to intervene and make corrections while a shipment is in transit.
MW: Do you try to reduce the environmental impact of transport? If so, how?
MS: Cryoport’s Cryoport Express® shippers are totally green and non-hazardous. All of the components of our shippers are recyclable. Additionally, the data we collect from our Cryoportal® enables us to optimize shipping lanes so that the most efficient logistics solutions are chosen.
MW: What regulatory requirements do you have to adhere to?
MS: Our Cryoport Express® shippers are International Air Transport Association (IATA) and International Safe Transit Association (ISTA) certified.
Cryoport conducts ISTA 7D, 7E, and 3A testing and validation on their equipment to ensure that they will hold temperature for a predetermined amount of time and will be able to be transported on commercial aircraft without damage to the packaging, contents, or at risk to anyone coming into contact with the package.
Also, the Cryoportal® is 21 CFR Part 11 compliant. 21 CFR Part 11 compliance is a regulatory requirement by the FDA that requires you to retain all records and identify any access, or changes to the data or contacts by any person such that they cannot be corrupted.
Moreover, Cryoport is the only entity in the space that supports “Chain of ComplianceTM” processes, which is full traceability of the equipment, commodities, systems, and processes.
MW: What are the main areas of biopharma that are driving the growth of your business?
MS: The main driver is the growth in regenerative therapies. As of the end of 2018, there were 1,028 clinical trials underway, up from 631 at the year end 2015. Also, the first two commercially approved cellular therapies, Kymriah and Yescarta, have started to ramp.
MW: What is Cryoport’s focus for 2019?
MS: Cryoport’s main focus is to grow our leading regenerative therapy customer base by continuing to provide the best in class solutions and support. We must continually improve our products, processes, and procedures to serve this ever changing and evolving sector.
Cryoport has been focused on capturing the majority of the regenerative therapy market from a packaging and distribution support standpoint over the last 4 years.
We have successfully captured more than 300 clinical trials in the space, a market share of more than 30%.
We intend on expanding our share into 2019 through capture of additional clients and trials as well as add new products such as our consulting capabilities and 2-8°C shippers to expand the business we have with current clients.
Mark Sawicki was speaking to Michele Wilson, Science Writer for Technology Networks.