Cryoport forms consulting division to tackle biological cold chains
April 19, 2016
Cryogenic logistics company Cryoport has launched a temperature controlled logistics consulting division to help life sciences companies develop strategies for global cold chain logistics management and contingency options to protect their valuable, and often irreplaceable, biological commodities.
The division aims to address the demand created by the worldwide advances in cellular based therapies, including immunotherapies, stem cells and CAR T-cells. Cell-based immunotherapies are causing broad shifts and challenges for the life sciences industry, including how to obtain, properly store and transport the growing number of new, individualised, temperature sensitive therapies.
Improper temperature maintenance or temperature excursions during any portion of a logistics journey can adversely affect the viability of these biologically based commodities, quickly destroying tens of thousands to millions of dollars of irreplaceable life-saving material. Consequently, strategic, global logistics planning for cryogenic cold chains has taken on a strategic importance to the life sciences industry and a rapidly growing demand for consulting expertise.
From a logistics point of view, the issue at hand is that biopharma commodities for clinical trials, therapies, drugs and supplies has historically been an afterthought due to a lack of options and the relatively low cost to replace product that was lost or damaged. The new cell-based therapies are often irreplaceable or have extremely long manufacturing cycles that drive up their value. This changes the logistics landscape from a commodity service to a critical path planning project. Traditional systems for global fulfilment and distribution do not address this level of consultative planning.
These discoveries and innovations in the development of individualised cell-based therapies and drugs have catalysed an increased focus on the importance of the control of temperatures from manufacturing and distribution to the point of patient administration. For cellular therapy efficacy to be delivered, comprehensive logistics strategies and planning are critical.
Each facility that looks to implement cellular based programmes must develop cryogenic storage, distribution and fulfilment systems that can track individual patient-based drug product, maintain the proper environment, and provide proof from collected and vital monitoring information regarding the chain of condition and chain of custody.
Many of these therapies require both cold chain and frozen chain segments within the programmes and maintaining cell viability is the greatest risk. Facility advancement in cold chain systems requires extensive planning, advanced technology platforms and a deep industry expertise.
Cryoport is experienced at developing customised systems to meet what seems to be an ever-increasing demand from the biopharmaceutical industry. To address successful global cold chain logistics including storage, fulfilment, distribution and information strategies, the California company’s consulting division will assist life sciences partners in devising and implementing strategies for dependable global logistics tailored to their needs.
The division is headed by Tamie Joeckel, who recently joined Cryoport’s executive team as senior vice president for client services. Joeckel has over 25 years of pharmaceutical industry logistics experience having worked with companies such as Amerisource Bergen, McKesson, Parexel and Dohmen Life Sciences. She has been a key member in commercialisation strategies, distribution and manufacturing for a number of companies and products.
Her consulting experience is partially the result of having participated in the launch strategies for more than 20 biopharmaceutical therapies.
“The cellular therapy and, more broadly, life sciences industry is investing billions of dollars to advance therapies that are changing the face of modern medicine,” she said. “It is imperative that companies in this space confer with experts in cold chain logistics as early as possible for feasibility and programme execution planning required to help mitigate risk and ensure success in global programmes. Whether in phase one, two or three in clinical trials or planning for commercial launch of a new therapy, global planning is critical. We recognised this as a great opportunity for Cryoport.”
Today, Cryoport is supporting 64 clinical trials in the regenerative medicine space. In addition, it supports more than 500 clients globally by providing logistics for biologic materials, such as immunotherapies, stem cells, CAR T-cells and reproductive cells.
“We are indeed excited about our expansion into consulting,” said Jerrell Shelton, chief executive officer of Cryoport. “Our many years of systems and logistics development have put Cryoport in a unique position to provide life sciences industry companies with a wealth of knowledge and best practices for cryogenic cold chain logistics.”
He said the division was equipped to provide clients with guidance and information about advanced cold chain logistics. This initiative was conceived in response to direct demand from both new and existing life sciences clients of Cryoport.
“It is a fact that the life sciences industry is becoming increasingly aware of the importance of cold-chain logistics challenges that they will face over the next decade,” he said. “As the recognised industry leader in cryogenic logistics, we are committed to the support of the life sciences industry at large. As for financial impact, we cannot forecast the growth of this new division precisely, but we have discussed our service with a number of life sciences companies and expect it will have a meaningful revenue impact over time.”