Cryoport launching logistics study for bioanalytical and clinical trial materials
“The reason we launched the study is that there is very little peer reviewed scientific data available today in the scientific arena that looks at the effect of various conditions such as temperature and shipping container choices and their impact on viability of clinical cell line material or biomarkers,” Mark Sawicki, Ph.D., Chief Commercial Officer of Cryoport, Inc., told Outsourcing-Pharma.com.
The study will be completed in partnership with KCAS Bioanalytical and Biomarker Services ("KCAS") and Heat Biologics, Inc. ("Heat").
For Cryoport, Sawicki said the company decided to launch the study so its clients could be better informed on the appropriate temperature and conditions for both cell-based materials and bioanalytical samples to support their clinical trials.
Ultimately, Sawicki said the goal is to better educate the industry on shipping choices for clinical data integrity, and that the timing of the study “certainly comes at a crossroads.”
“The science has advanced on both sides,” said Sawicki, “the materials that are being shipped are no longer simple but are extremely complex and the materials and software being used on the logistics side are more robust than ever.”
“We hope to gain accurate scientific data that demonstrates the most appropriate shipping conditions for cell based therapies and biomarkers,” added Sawicki, who said that there are “far reaching consequences to this study,” as biomarkers are involved in clinical studies across the world.
“If people are shipping bio markers sub-optimally at this time, it will impact clinical trials all over the world,” he said. “With the data from this study, we can help ensure that all the clinical trials in the world are using the most optimal shipping for bio markers and cell therapies.”
According to Sawicki, preliminary data is already supporting temperature selection as correlating to biomarker integrity.
