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Application in Bioprocessing

Mammalian cells are widely used in Biopharmaceuticals, such as antibodies, vaccine, peptides and secondary metabolites are produced by bioprocessing with mammalian cells. During the whole process from antibody R&D to production, there are many steps need to carry out cell based assay to evaluate the process or quality control. Such as the total cell concentration and viability will define the status of the cell culture. As well as the cell transfection, antibody affinity determine at cell level. Countstar instruments are the image based cytometry, can help monitor from R&D to production processes and ensure reproducibility and consistency.
Table of Content

  • Cell Count and Viability by Trypan Blue Staining Principle

    Monitoring and analyzing cell culture with state-of-the-art solutions. Reliable and efficient monitoring is crucial for optimizing yield and product quality since even small changes in bioprocess parameters can influence the performance of your cell culture. Cell count and viability are the most important parameters, Countstar® Altair supplies an extremely smart and fully comply with cGMP solution for these.
    The Countstar® Altair is designed based on the classic Trypan Blue exclusion principle, integrating the advanced “fix focus” optical imaging bench, the most advanced cell recognition technologies, and software algorithms. Enable to get the information of cell concentration, viability, aggregation rate, roundness, and diameter distribution by one run.

    Cell Count and Viability by Trypan Blue

  • Viability and GFP Transfection Determination in Cells

    During the bioprocess, GFP is often used to fuse with recombinant protein as an indicator. Determine the GFP fluorescent can reflect the target protein expression. Countstar Rigel offers a fast and simple assay for testing GFP transfection as well as viability. Cells were stained with Propidium iodide (PI) and Hoechst 33342 to define the dead cell population and total cell population. Countstar Rigel offers a quick, quantitative method for evaluating GFP expression efficiency and viability at the same time.

    Viability and GFP Transfection Determination in Cells
    Cells are located using Hoechst 33342 (blue) and the percentage of GFP expressing cells (green) can easily be determined. Nonviable cell are stained with propidium iodide (PI; red).

  • Affinity of antibody detection on Countstar Rigel

    The affinity antibodies are usually measured by Elisa or Biacore, these methods are very sensitive, but they detect the antibody with the purified protein, but not natural conformation protein. Use cell immunofluorescence method, user can detect the antibody affinity with natural conformation protein. Currently, quantification of the affinity of antibody is analyzed by flow cytometry. Countstar Rigel also can provide a quick and easy way to evaluate the affinity of antibody.
    Countstar Rigel can automatically capture the image and quantitative the fluorescence intensity which can reflect the antibody affinity.

    Affinity of antibody detection on Countstar Rigel.
    Affinity of antibody detection on Countstar Rigel
    Diluted the antibody into different concentrations, then incubated with the cells. The results were obtained from Countstar Rigel (both image and quantitative results)

  • Countstar is GMP-ready for 21 CFR Part 11

    Countstar instruments fully comply with 21 CFR and Part 11, the IQ/OQ/PQ services ensure control of the consistent operation. Countstar instruments are ready implemented in GMP and 21 CFR part 11 compliant laboratories. User control and audit trails allow for adequate documentation of usage with standardized PDF reports.

    Countstar instruments fully comply with 21 CFR and Part 11, the IQ/OQ/PQ services ensure control of the consistent operation. Countstar instruments are ready implemented in GMP and 21 CFR part 11 compliant laboratories. User control and audit trails allow for adequate documentation of usage with standardized PDF reports. IQ/OQ documents and validation partials
    IQ/OQ documents and validation partials
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