During the last year, cold chain logistics firm Cryoport has established collaborations and boosted its revenue by supporting the numerous clinical trials on going in the industry. According to a PhRMA report, there are currently approximately 300 cell and gene therapies in the various stages of clinical development.
The latest move sees Celularity, a clinical-stage allogeneic cell therapy manufacturer, agree to utilize the temperature-controlled solutions of Cryoport.
This adds to the previous deals sealed for the exclusive distributions of Novartis’ Kymriah (tisagenlecleucel) and Kite’s Yescarta (axicabtagene ciloleucel), both of which are US and EU-approved chimeric antigen receptor (CAR)-T therapies.
Cryoport’s first-quarter earnings for 2019 is expected to be published on May 2. Ahead of these being published, BioPharma-Reporter (BPR) spoke to the company’s CEO, Jerry Shelton (JS), about the importance of the company’s latest deal and the position that the logistics industry can claim within the growing cell therapy market.
BPR: Could you outline the importance of the deal with Celularity?
JS: Cryoport will support Celularity in many of its supply chain functions, especially in logistics and we're very excited to contribute in the important developments they are undertaking. It is an honour for Cryoport to help bring revolutionary therapies to the market. Allogeneic therapeutics is a promising market and Celularity is led by world class leadership. I would like to refer to Robert Hariri as the inventor of modern day placental medicine.
BPR: In what ways has Cryoport agreed to support Celularity’s clinical trial activity?
JS: Celularity owns two of the most important patents in the world of stem cell research. In Phase II, [treatment] indications are for multiple myeloma and also AML [acute myeloid leukemia], another form of cancer. Treatments in Phase I are for glioblastoma multiforme tumors and Various Hem/Solid tumors. We are very optimistic about their success – our expectation is to support the clinical trials, in terms of logistics, and to increase that support as we expand and grow our capabilities at Cryoport. In the supply chain, Cryoport offers logistics, packaging services, as well as information technology and consulting. With all those services we will be available to support Celularity.
BPR: How has the growth of the cell and gene therapy market been affecting Cryoport’s activity?
JS: The demand in cell and gene therapy is very robust. It is said that the cell and gene therapy market will grow 10 times, or even more, over the next four or five years. Cryoport is the unique provider of logistic services supporting the cell and gene therapy. We're in a very special place and we work hard to maintain that position and to be able to support all the new therapies coming to market, with the revolutionary cures for terrible illnesses, like cancer.
BPR: In what ways do Cryoport’s services respond to the specialized needs of cell and gene therapeutics’ shipping?
JS: Cells are degrading in their natural state – they are programmed to die. In order to deliver efficacy, we have to stop or slow down the metabolic activity and take them to a level of suspension. We achieve this through temperature control and that is what makes monitoring so crucial for scientific, as well as regulatory purposes.
It all begins with our packaging, which we call Cryoport Express Shippers, which are complex, highly engineered shipping packages, made through packaging engineering, mechanical engineering, material engineering and electronic engineering. The electronic engineering connects to our monitoring system. Through its electronics, the packaging communicates to Cryoportal, our logistics management system.
The monitoring system gives real time information on the conditions in which the commodities are being shipped. We monitor all the necessary variables, such as internal temperature, external temperature, barometric pressure, humidity and orientation of the package. However, we can also tailor a lot of different variables for the client, to assure that the conditions have been met and deliver efficacy of the therapy being shipped. Afterwards, we archive those information for future use.
The other bucket of tools that we work from is our logistics expertise. We actually know the performance of every integrator, every courier and every supplier that we use in the world.
Jerry Shelton is the CEO of Cryoport. Previously, he was a visiting executive at IBM Research, where his team created and developed WebFountain, a project contributing significantly to IBM’s software strategy. He was also president and CEO of NDC Holdings, Continental Graphics Holdings, Thomson Business Information Group and Advantage Companies.
