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Screening a large number of clones as soon as possible to select valuable clones for further analysis is critical for GMP cell line development. Creative Biogene offers an automated cell isolation and screening platform to quickly and efficiently obtain, evaluate and validate large numbers of viable and high-yielding monoclonal clones from a single cell pool, providing customers with a time- and cost-efficient solution.
Despite the identification and enrichment of highly productive Pools of cells through a range of techniques, however, the Pools screened at this point still belong to a heterogeneous cell population, and it is possible that each of these cells has unique genetic and phenotypic characteristics. If there is a small difference in the growth rate and cell specific productivity of the cells in the pool, a growth advantage of only 9% in this case is sufficient to over-proliferate the cells within 25 generations, which means that industrial production must be done with monoclonal clones that are highly homogeneous in terms of genes and phenotype. At the same time, regulatory agencies only accept the use of cloned cells for the production of biological drugs. This further implies that the cells used for production must be homogeneous cells cloned from a single cell, thus requiring further monoclonalization of cell pool and selection of clones suitable for large-scale production, as well as monoclonal verification of cell lines.
Antibody screening and titer ranking
Creative Biogene scientists perform discovery and selection of high-value clones from transfected cell pools. Large populations are screened by quantifying the surface expression or secretion of antibodies (titer ranking) for proteins of interest to identify opportunities for high producers or high affinity binders.
Single cell isolation and cell viability assays
Isolation and cloning of single viable cells is necessary to ensure that cell populations are genetically identical and that expression heterogeneity is significantly reduced.
Monoclonal verification of cell lines
Monoclonal source validation is designed to reduce the heterogeneity of cell banks, maintain consistency and predictability in the production process, and ensure that the yield and quality of the final product are within predetermined limits. Creative Biogene provides image-based documentation for adding to regulatory filings.
Fig. 1 Top clone screening strategies at Creative Biogene.
Creative Biogene offers an automated screening strategy through the use of high-throughput monoclonal screening devices. This strategy overcomes the limited nature of the finite dilution method and flow cytometric fluorescence sorting (FACS) technology and has the advantages of low human intervention, high throughput and high efficiency, greatly simplifying the cell line production process and improving screening efficiency and accuracy.
As a leading provider of GMP cell line development services, Creative Biogene is committed to using our advanced technology and innovative solutions to help you reduce the time required to isolate and produce monoclonal cell lines and provide high-value monoclonal clones for subsequent production. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.
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