Products Products We aim to realize the potential of the VACS technology: fast, sterile, scalable, gentle, reliable cell sorting. Our products eliminate the issues associated with conventional fluorescence-activated cell sorters, such as contamination/cross-contamination, aerosol hazard, cell damage, cell loss, clogging and variability. Not least, our sorters promise to make cell sorting a lot less time-consuming, with automation to stabilize the sorting process and notify the user, so that cytometrists no longer need to monitor the instruments live. Highway1 — now in beta Highway1, our first product, is a fluorescence-based cell sorter for sterile and GMP use. It consists of a benchtop instrument and a disposable single-use cartridge. Two versions of the cartridge are available labelled “RUO” and “GMP”. At the time of writing, Highway1 is a beta prototype. cGMP cartridge validation is in progress, expected completion mid 2022. Cellular Highways has the intention to launch Highway1 commercially in late 2022. More details of Highway1 are given below. Test data is also presented on our applications page. Please get in touch if you are interested in testing a beta prototype! Highway1 product features 43,000 per second sort envelope rate Recommended cell processing rates: 10,000/s in purity mode, up to 50,000/s in enrichment mode 2 lasers, 2 x scatter, 4 x fluorescence (to be expanded after the first release) Benchtop, small footprint, no sheath fluid, fits in standard biosafety cabinet Fully automated: load the cartridge, set the gates, walk away No aerosols; no cleaning, no contamination, no cross-contamination Highway1 specifications Note the list of specifications below describe the current specification and state of the beta prototypes, but are potentially subject to revision before launch. SpecificationDescriptionCytometry • 2 lasers (488 and 640 nm), spatially separated • 2 morphological parameters: FSC, SSC • 4 fluorescence channels corresponding to the emission bands of FITC, PE, PerCP, APC • Peak height and area measurements in all channelsInstrument • Benchtop instrument, designed to fit in biological safety cabinet if required by application • 570 x 210 x 320 mm (H x W x D) • Weight 20 kg • IP54 rating, instrument interior fully sealed and air-filtered for cleanroom use • Easy to clean and disinfect for use in lab environments • All-in-one control PC running Windows 10, supplied with instrument • Requires standard consumer mains electricity supply, 300 W max power (total of instrument and control PC) • Class I laser safety (fully engineered, interlocked, enclosed beam)RUO cartridge • For Research Use Only • Supplied sterile, intended for single use • Syringe input (5, 10 or 20 mL Luer syringes) • A 20 mL syringe is supplied with each cartridge in a sterile pack including syringe loader with cell strainer and magnetic stirrer • Cartridge outputs are two 15 mL centrifuge tubes (sort1 and sort0)GMP cartridge • For compatibility with current Good Manufacturing Practice (cGMP) regulations • Meets the necessary standards (USP and ISO) to enable safe use in cell therapy manufacturing • Weldable input tube and output bags for aseptic connection • Sterilization validation • Biocompatibility validation studies (Cytotoxicity, Sensitization, Pyrogen, Systemic Toxicity) • Extractables validation study • 100% leak tested in production • Cartridge documentation to support use as ancillary materialSystem performance • Purity 97%, yield 66% (typical performance for well-suspended non-sticky cells in size range 5 – 20 µm, pre-sort positive > 5%, sorted in purity mode) • 20 mL flows in < 1 hour 30 minutes, to process up to 60e6 cells (purity mode) or up to 270e6 cells (enrichment mode) • Highly automated operation: set up and walk away • Automatic flow-clear, automatic adjustment of actuation parameters, automatic tracking of sort fidelity • Failsafe automationSoftware • Operation and analysis provided on proprietary HighwayS software, on Windows 10 • Data output in standard FCS format Highway16 Highway16 is a parallelized version of the VACS technology. In 2021 we published a proof of concept study, demonstrating a 16x parallel VACS chip – the fastest cell sorter in the world, achieving approximately ten times the headline performance of high-end fluorescence-activated conventional sorters used for sorting blood cells. The demonstration achieved a purity-mode throughput of 200,000 particles per second, extrapolating to 0.7 billion per hour. (The equivalent droplet rate is 688 kHz.) Watch this space for announcement of our Highway16 alpha prototype, anticipated late-2022.