JULY 12--Beckman Coulter Inc. (Fullerton, CA;
www.beckmancoulter.com) has shipped the first orders for the its new Vi-CELL cell-viability analyzer. The Vi-CELL automates the widely accepted trypan blue-dye exclusion method for monitoring cell viability and also can be used for production control during the manufacturing stage of the biotech industry's rapidly expanding recombinant DNA process for the production of bio-active molecules.
Designed around a novel flow cell that ensures that all cellular material being analyzed is always in focus, the Vi-CELL captures numerous images of the cellular population with its high-resolution CCD camera. The images are analyzed using a propriety algorithm for gray scale. Nonviable (dead) cells absorb the trypan blue stain as a consequence of their cellular membranes losing integrity. As a result, they become darker in color in relation to the viable cells present. It is this difference in color (tone) that is measured using the Vi-CELL.
Vi-CELL offers numerous advantages over the current manual method. For instance, a typical analysis using the Vi-CELL system will measure thousands of cells, ensuring a high degree of accuracy and reproducibility. The manual hemocytometer method, by comparison, typically measures less than 100 cells and is very subjective. The Vi-CELL software featuring electronic signature capability, will aid with 21 CFR Part 11 compliance, and is available with a full equipment qualification system (IQ,OQ,PQ) to address validation issues.
In addition to viability, the Vi-CELL reports parameters including size, circularity (shape), cell count, viable cells within a population, and total and viable cells per milliliter. A major feature in the software is the bioprocessing tracking option, which allows for complete tracking of a bioprocess (fermentation) over time, reporting such parameters as doubling time and growth rates. For maximum throughput, the system can be configured with a 12-position continuous feeding auto-sampler. Vi-Cell adheres to Standard Operating Methods, ensuring the benefit of standardization, while offering the maximum flexibility for users monitoring multiple cell lines.