The basis of manufacturing biologically active products relies on generating high quality cell lines which comply with current regulatory guidelines. However, the construction of a validated cell line requires sophisticated and time-consuming work. We use Glutamine Synthetase (GS) or Dihydrofolate Reductase (DHFR) systems to construct the stable cell lines. Recombinant clones will be selected for target expression analysis and qualified by their performance in a functional cell-based assay. We develop not only high expressing clones but also those which are capable of a successful transfer to large scale protein production.
Cloning of the provided cDNA into a suitable expression vector. Codon optimizations can be introduced for the high yield production.
Transfection of host cell line which is compliance with FDA guideline.
Selection of stably transfected cells.
Isolation of cell clones by efficient and time-saving strategy.
Screening of clones by target expression titration.
Selection of recombinant cell lines at the highest expression level and preparation of cryostocks.
Quality control of cell line stocks for viability and sterility including mycoplasma testing.
Free cell line backup service for two years from delivery of cell clones.
Profacgen can provide the highest compliance to regulatory guidelines. This includes identification of genetic, transcript and product stability during cell line as well as process development.
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