Catheter Manufacturers to Find Guidance in Proposed Standard
Catheter manufacturers have found that properties of their devices can influence performance of delivered cell therapy products. However, there is wide variability in how delivery device effects on cell performance are evaluated. A proposed new ASTM International standard will help eliminate this confusion and provide guidance to manufacturers on how to measure the effects of their devices on delivered cells.
The proposed new standard is WK46706, Guide for Medical Device Compatibility with Delivered Cellular Therapies. WK46706 will outline the parameters to consider when designing benchtop tests to assess the potential impact of the delivery device on the cellular product being dispensed.
ASTM member Carl Simon Jr., a biologist at the National Institute of Standards and Technology, notes the importance of the devices to be covered by WK46706. "Catheters and other cell delivery devices are used to deliver cell therapy products to patients. For instance, a catheter may be used to infuse cells into the venous or arterial vasculature of the heart to address acute ischemic injury to myocardial tissue."
Primary users of WK46706, when approved, will be delivery device manufacturers, companies that make cell therapy products and regulatory bodies.
The proposed standard will be divided into three sections:
- The first section will outline what constitutes an acceptable representative cell type or reporter cell system if using device extracts.
- The second section will outline what parameters of cell physiology should be measured to make a determination of cytocompatibility.
- The final section will outline the thinking on testing components individually or as assembled for delivery, use of worst case setups, delivery device exposure conditions, appropriate density of cells to use during tests and similar items.
WK46706 is being developed by Subcommittee F04.42 on Biomaterials and Biomolecules for TEMPs, part of ASTM International Committee F04 on Medical and Surgical Materials and Devices. F04.42 encourages interested parties, particularly experts in the delivery of cell therapy products, to participate in the development of WK46706. This includes cell delivery device manufacturers, relevant staff from regulatory bodies and experts from cell therapy product companies.
CONTACT Technical Information: Carl Simon, Jr., National Institute of Standards and Technology • Gaithersburg, Md. • Phone: 301-975-4977 | ASTM Staff: Pat Picariello • Phone: 610-832-9720 | Upcoming Meeting: May 19-22, 2015 • May Committee Week • Anaheim, Calif.
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