Organizing shipping studies to evaluate the transferability of cell- and tissue-based test systems and reagents: An end user perspective

Abstract

Cell- and tissue-based test systems and reagents (e,g., cells, tissues, organs, reconstructed tissue models, or cell/tissue culture reagents) are increasingly being used in regulatory and non-regulatory testing applications due to their ability to reflect human biology. These test systems and reagents may be shipped long distances, including across international borders, from the vendor to the testing laboratory. To ensure confidence in the data obtained from testing involving these systems and reagents, it is important for the testing laboratory to confirm that quality is maintained during the shipping process and that the materials can be used for their intended application (i.e., that the test method associated with the test system and/or reagent can be effectively transferred between laboratories). This paper describes various types of shipping studies that might be conducted when transferring a method to a new laboratory and key considerations for their design that can help maintain the quality of the test systems and reagents during the shipment process. Furthermore, emphasis is placed on the need for good communication between vendors, shipping agents, and end users to ensure efficient transferability of test methods.

Plain language summary
Transfer of test methods between laboratories is dependent on the availability and accessibility of the cell- and tissue-based test systems and reagents needed to conduct the experimental work. The logistical aspects that make the execution of laboratory studies possible are sometimes overlooked or underestimated even though they play a significant role, especially when international shipping is involved. The test systems or reagents might be time- or temperature-sensitive and have a relatively short shelf-life. Therefore, meeting the conditions that maintain their performance within expectations is of the utmost importance. Our manuscript shares insights from the perspective of end users (a testing laboratory and client) of such test systems and reagents incorporated in toxicological studies. By sharing these insights, we aim to provide support to other laboratories involved in similar projects and thus avoid loss of resources while troubleshooting any challenges encountered during the transferability process.