Cell counting in CAR T cell therapy
For a consistent process, and product, a consistent cell counter is required. The NucleoCounter® NC-202™ is a leading automated cell counter in CAR T and other CGT workflows for its reliability in cell therapy production. Important features include:
- Low variation: Our instruments are the most precise on the market due to our unique approach to calibration and automated sample handling.
- Fast: 30 seconds after pressing “run,” your results are ready for view and export.
- Objective cell counts: Fluorescence microscopy using dyes AO and DAPI provides an objective means of determining cell viability.
Security and integrity
The NC-202™ works with NC-View™ software, which provides objective and accurate analysis of your cells throughout the cell manufacturing workflow. NC-View™ can be integrated into any cGMP set up to ensure date integrity and security when used in restricted mode.
- 21 CFR Part 11-ready: NC-View™ works in cGMP settings to comply with 21 CFR part 11.
- Audit trail: NC-View™ tracks all actions within the software, which is available for view and export.
- Controlled access: Defined user groups provide different levels of access. No user is able to modify data during acquisition or after storage of data.
Features
Time-Saving
Easy to use
Inexperienced users can achieve just as low variation as those experienced in the NucleoCounting™ method. Yes, it’s that easy.
Precision
We’ve tested the NC-202™ on more cell lines than any other cell counter has been tested on and compared performance between instruments. From these results, we can say it’s the most precise instrument on the market.
Reliability
As we say: any sample, any user, anywhere and anytime. Your results vary minimally between instruments, users and sites, supporting process and tech transfer.
Success Stories
Here are a few we are especially proud of.
Read them all on SelectScience.
Will Milligan: "Counts cells quicker than any counter I've ever used!"
Exmoor Pharma Concepts
"It performs cell counts quicker than any counter I've ever used! No sample prep required, just load a cartridge, load it in the system and hit go."
Debra Carter: "Literally panic if unable to use this machine"
Microfluidx
"... the one time we had something go wrong (after 3 years of use) the engineer turned up within 2 hrs and fixed it!"
Jason Lamar: "Awesome little device"
Genentech
"Excellent little machine; very easy to use. Have not had any issues over the last year we have been using."
Frida Larsen: "Great time saver."
Sci-Group
"Very quick and easy to use. The machine saves us a lot of time and the results correspond to those obtained with other methods."
Let us show you how
The NucleoCounter® NC-202™ is a state-of-the-art cell counting solution that fits into any CAR T cell or other CAR-cell therapy manufacturing process. It ensures consistency across users and locations, providing reliable data you can trust. This advanced cell counting solution offers unmatched accuracy in cell counting and analysis.
Equipped with cutting-edge technology and features, the NC-202™ is tailored to meet the unique needs of cell therapy applications.
Here are the key features:
- Via2-Cassette™ Technology: Cassette-based technology eliminates human error and enhances reliability in the manufacturing process.
- DebrisIndex™ Monitoring: The NC-202™ measures culture debris, aiding in optimizing cell therapy manufacturing processes.
- 21 CFR Part 11/GMP-ready Software: NC-View™ software integrates seamlessly into clinical workflows, ensuring regulatory compliance.
- Automated Viability Measurement: This feature helps streamline cell viability assessments, ensuring consistent results.
- Accurate Cell Counting: The NC-202™ uses advanced technology for reliable cell quantification.
- User-Friendly Interface: The NC-202™ simplifies operations, reducing training time and errors.
Don’t settle for less than the best when it comes to your cell therapy manufacturing. Choose the NucleoCounter® NC-202™ today and see the difference for yourself.
FAQ
What makes the NC-202™ a leading choice in CAR T cell therapy workflows?
The reason “the process is the product” still dominates thinking in cell and gene therapy is due to the variable starting material of these medicines. For this reason, minimizing process variability is one of the central challenges to overcome when building a scalable manufacturing process.
Precise cell counting is also needed after manufacturing, in order to correctly dose the therapy. For example, after cryopreservation, the NC-202™ is often used to determine viable cell count. Throughout all of these steps, having a clear understanding of cell number and cell viability improves understanding of your product. However, with a highly variable cell count, controlling critical process parameters is more difficult.
What are the features of the Via2-Cassette™ system that eliminate human error and reduce exposure to toxic reagents?
The Via2-Cassette™ is a disposable cassette that is used to sample cells, stain them and ensure a precise volume is analyzed. This lab-on-a-chip technology automates these steps, thereby improving the precision of the measurement. Watch the video below to see it in action.
Elements of the cassette include:
- Integrated pipette: The Via2-Cassette™ functions as a single-use pipette. After pressing down the piston, 60 μl of your sample are drawn into the cassette.
- Pre-loaded fluorescent stains: The cassette contains AO and DAPI which instantly stain the cell sample.
- Volume-calibrated: There is a cell counting chamber in the cassette that is calibrated at the point of production. Using a dot code, the NC-202™ knows the exact volume of the cell sample in this chamber, for accurate cell concentration measurement.
- Safe work environment: By choosing fluorescent dyes and pre-loading them, we create a safer environment for operators compared to using trypan blue.
How does the NC-202™ support the entire workflow for autologous and allogeneic cell therapy manufacture and delivery?
Many analytical instruments are needed throughout the workflows for cell and gene therapies. Cell counting is a crucial step found from the very beginning of cell harvesting all the way to delivery. For autologous therapies, the NC-202™ is used to count cells from leukapheresis to product release.
A robust cell counter, like the NC-202™ counts a wide variety of mammalian cells and can handle tricky cell samples, including those with debris and aggregated cells.
How does the NC-202™ ensure consistent results across different instruments, users, and sites?
Through its ease of use, pre-calibration and precision technology, when we take several samples and measure them on the NC-202™ we obtain very low variation. We replicate this result in different users and even sites.
There are many reasons why analytical instruments vary over time. Temperature, humidity, calibration issues, movement and other factors can impact an instrument’s performance.
The NC-202™ does not use a flow system. By opting for disposable cassettes, the instrument itself only performs a cell count. A Via2-Cassette™ is needed to sample your cells and stain them. This cassette performs these functions simultaneously, after the operator presses down on the cassette’s piston.
By using fluorescent dyes, AO and DAPI, the NC-View™ software clearly shows live and dead cells, eliminating the need to guess, as in manual cell counting.
All our instruments are pre-calibrated before release to one gold standard instrument that stays at our headquarters in Denmark. As a result, we do not calibrate our instruments using calibration beads and the performance of the instrument does not deviate over time.
How does the NC-View™ software support 21 CFR Part 11/GMP guidelines and integrate with clinical workflow?
The NC-View™ software can help you stay compliant with 21 CFR Part 11 when used in secure mode. This feature includes an audit trail, user access levels and the prevention of data modification.
- Audit trail: NC-View™ records an audit trail that is available for viewing and export by administrators. The audit trail records all actions in the software and cannot be modified.
- User authentication and access: In Secure Mode, NC-View™ requires user authentication against the Windows Active Directory database. Users must be logged in using their Windows login ID and password to access the software.
- Secure data storage: Cell counting data generated with the NC-202™ are stored in a proprietary data format, as a CM file. This file contains all data associated with performing a cell count, including electronic signatures.
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