GIBCO CTS XENON ELECTROPORATION SYSTEM (XENON SYSTEM)
A customizable, scalable electroporation system for GMP-compliant cell therapy manufacturingProduced by Thermo Fisher Scientific
Featuring programmable, flexible electroporation conditions, the CTS Xenon Electroporation System allows cell therapy developers to optimize a variety of hard-to-transfect cell types and payloads. Users can optimize multiple electroporation conditions simultaneously and identify the best electroporation conditions for unique cell and payload combinations. Once the ideal protocol has been identified, the system can be configured to a clinical manufacturing mode. The system has been specifically designed to enable an easier transition from the bench to the clinic.Over 1,000 cell and gene therapy candidates are in clinical trials, which means there will likely be demand for pharmaceutical services that outstrip supply. The Gibco CTS Xenon Electroporation System helps researchers overcome manufacturing challenges to bring cell therapies to more patients. Using the modular Xenon System for nonviral gene modification enables time-consuming processes such as cell expansion, to be decoupled from rapid processes, such as gene delivery, improving facility and equipment utilization, and reducing the capital investment required.KORUS
Cleaner cell populations through elutriationProduced by InvetechKorus is a closed system for autologous cell therapies that features elutriation and cell wash using gentle counterflow centrifugation. The system delivers purified cell populations for downstream processing development and commercial manufacturing, which Invetech says results in better overall process performance through higher recovery and purity of target cells. According to the company, there is supporting data demonstrating improved manufacturing performance compared to samples prepared by standard washing.The double rotor centrifuge means that Korus can produce a full leukopak in one run, enable developers to accelerate clinical development. The input volume range of 25 mL to 5L and efficient run times also enable developers of autologous therapies to use the system from process development through to commercial manufacturing. Korus elutes lymphocytes to high purity levels, resulting in downstream performance improvements, such as greater Dynabead cell selection recovery and fold expansion (compared with standard washing protocols). And that reduces the impact of starting material variability, contributes to higher manufacturing yield, and reduces the risk of batch failure – all contributing to potential reduction in the cost of goods for future therapies.
PIN MILL PMV-320
Milling/micronizing platform that renders product ignition or explosion impossibleProduced by Frewitt Engineering Works
From potent APIs to fuels and many other powder ingredients, numerous products are susceptible to explosion, oxidation, and heat damage because of the kinetic energy required for milling products to the necessary particle sizes. Potent APIs can also endanger employees during handling. Manufacturers are therefore obliged to install containment measures. With the Pin Mill PMV-320, the entire milling process takes place in a vacuum (negative atmosphere), depriving products of sufficient air to ignite, heat, or oxidize. The negative pressure atmosphere enables processes to be contained easily, without costly and complex security measures. Moreover, the process – despite turning at speeds exceeding 200 m/s – is almost silent, which also enables users to forego hearing protection.With a turn-key solution that does not require large amounts of nitrogen gas to mitigate explosion risk, Frewitt claims that the system will result in increased safety, while also helping preserve the active properties of medications by avoiding heat and oxidation.
