Cold chain logistics have become increasingly important for drug manufacturers as drug products have become more and more complex and temperamental. Cellular and regenerative medicines, stem cells, immunotherapies, and CAR-T cell therapies, in particular are among the most common types requiring such services.
 
Cryoport, a provider of cryogenic logistics solutions to the global life sciences industry, offers purpose-built packaging, information technology and specialized cold chain logistics solutions for biologic materials, such as immunotherapies, stem cells, CAR-T cells and reproductive cells. Global companies, such as FedEx, UPS and DHL have each selected Cryoport as their preferred cryogenic logistics provider for time- and temperature-sensitive biological material.
 
Mark Sawicki, chief commercial officer for Cryoport explains cryogenic logistics, the requirements, challenges, and regulatory issues around the transport of cellular therapies. –KB


Contract Pharma: What factors must be taken into consideration with cryogenic logistics?

Mark Sawicki: Chain of custody – Clients need continuous information on the condition of their materials during shipment. One temperature excursion will impact the integrity of the sample.
 
Security of the materials – Clients want to ensure the materials have not been tampered with. 
 
Viability in transport – Shock-absorbing packaging is necessary to reduce cell membrane-disruptive vibrations, delivering cells in the same condition as when they left.  
 
Customs clearance – Clients will want to know they have someone working for them that can respond to issues that may arise as their package clears customs. Customs documentation is critical and if not completed correctly can delay shipments.
 
Resource optimization – It is beneficial to have packaging that maintains temperature integrity for an extended period of time to account for shipping time and customs clearance (as applicable) while allowing organizations to maximize the productivity of personnel.
 
International regulations – It is important to understand the various regulations related to shipping biomaterials internationally.
 
Challenges in emerging markets – In certain emerging markets, there can be insufficient temperature-controlled storage facilities, inadequate shipping resources and a lack of understanding of shipping biomaterials.
 
Transparent shipping process – Clients want to know where their package is and the condition of the contents at every point in the journey.
 
Validation – Clients need to understand the validation and qualification processes of the dewars being utilized to ship their materials. A formal quality process should be in place to manage any fleet utilized to transport clinical trial materials.
 
CP: What are the main logistic challenges and how can they be overcome?
 
MS: There are two main challenges: risk mitigation and complete visibility.
 
It’s important to address a client’s specific needs in order to identify pain points in the existing process and mitigate risk. We work with clients to develop a customized approach to assess the risk in their shipping lanes and material handling/transport and create a strategy to address and remove the risk.
 
The other challenge is complete end-to-end visibility. We ship very important biomaterials that will be used in critical research or used to provide a life-saving therapeutic to a patient. Clients want to know where their materials are every minute of the day and that they have been maintained at the right temperature. Our technology solution, CryoPortal provides complete visibility and enables users to manage the entire process online. A software solution that tracks the material across the chain of custody is an absolute must.
 
CP: How are these products manufactured/packaged for delivery?
 
MS: We provide a shipping container (dewar) that maintains a temperature of -150°C and contains a constant tracking and monitoring system. We supply the box that it is shipped in all the way and include a return label on the dewar to make it easier for clients to ship it back to our warehouse to be revalidated.   
 
CP: What are the regulatory/compliance issues around the transport of cellular therapies?
 
MS: Regulations are evolving. Regulatory bodies and industry organizations are framing new guidelines governing the distribution of temperature-sensitive pharmaceuticals and clinical trial materials. Guidelines relating specifically to the cold chain are in place in Argentina, Australia, Austria, Bahrain, Brazil, Canada, China, the Czech Republic, Egypt, India, Ireland, Italy, Jordan, Mexico, Romania, Singapore, Saudi Arabia, South Africa, South Korea, the United Arab Emirates, the United States, Syria and Venezuela. The Food & Drug Administration, the Parental Drug Association, the U.S. Pharmacopeia, the International Air Transportation Association and other organizations also have established guidelines for the transportation of temperature-sensitive life science products. 
 
CP: On what scale are you seeing the development and manufacture of cellular therapies?  What do you anticipate in the near term?
 
MS: Based on the research we have seen, regenerative medicine is expected to grow anywhere from 12% to 20% over the next several years due to the commercial launch of programs currently in Phase III. When we combine this with the new immunotherapies in clinical trials, we expect there to be a significant increase in demand for cryopreserved shipping (multiple orders of magnitude), cold chain risk mitigation and advanced end-to-end technologies to track the shipment of these more individualized therapeutics.

Dr. Sawicki has 15 years of business development and sales management experience, having delivered on corporate revenue and market share goals in the pharmaceutical and biotechnology industries. Dr. Sawicki was most recently the Chief Business Officer at AAIPharma Services Corporation/Cambridge Major Laboratories Inc.; additionally, he has served in senior business development roles at CMC Biologics and at Albany Molecular Research Inc. (AMRI), where he increased revenue at rates far outpacing industry standards. Dr. Sawicki has authored a dozen scientific publications in drug discovery with a focus on oncology and immunology.