Overcome the inherent challenges of cell therapy production
Challenges in the production of cellular therapies are many, including safe navigation in a dynamic regulatory landscape, quality and consistency of processes, and safety and productivity, all in a cost-effective manner. Whether allogenic or autologous in nature, your cells require impeccable processing. That’s where we come in. From cell preparation and cell growth to cell expansion, cell harvest and storage, to transport, we are with you at every step of the way.
Hydrogen peroxide (H2O2) is a highly effective antimicrobial agent. Due to this property, and its availability and relatively low cost, it is commonly used as a sterilant in many areas where microbial contamination must be reduced or eliminated.
Seal integrity of a container is critical to prevent loss of contents or contamination from outside sources. Since plastic is a malleable material, forces borne at the thread and mating surfaces of the closure of a plastic container can deform the material over time or under certain environmental conditions.
While most organizations test their dry shippers before using them, the tests tend to be in an upright position with little or no movement. In transit the dewar can assume many different orientations ranging from upright to upside down and everything in between. This has a major impact on static hold time. A dry shipper on its side can lose as much as 60% of its hold time in a few hours. A large dry shipper transported upside down for even a few hours can go from days of hold time to hours.
The qualification and validation of production, harvest and containment supplies is an integral part of any Biopharmaceutical application process. Regulatory guidelines around the World recommend that the production, storage and packaging components be assessed for extractables or leachables that may interact with or impact the product being manufactured.
Cellular and stem cell information videos
See how Thermo Scientific customized fluid transfer systems can simplify adherent cell culture production.