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What is a Recombinant antibody?

Recombinant antibodies (rAbs) can be manufactured using synthetic gene fragments expressed in various in vitro antibody display platforms, such as yeast, bacteria or mammalian cell lines. This is a biologically and chemically defined animal-free system, which has a number of inherent advantages over traditional hybridoma based technologies.

Recombinant antibodies are biologically defined, with a known DNA and protein sequence, and as such it is ensured that the identical antibody is produced in each manufacturing batch. The possibility of genetic drift associated with hybridoma-based systems is removed completely and recombinant antibodies lack variability due to additional light chains that are often present in hybridomas. In addition, the manufacturing process is chemically defined, giving ultra-low batch-to-batch variability. The use of expression systems eliminates contamination from serum components, such as bovine albumin and IgG, leading to a product with very high purity (>98%).

Recombinant antibodies can be engineered at the genetic level enabling production of recombinant antibody fragments, e.g. Fab and Fab2, bispecific antibodies, site-specific conjugation of antibodies and a myriad of other possibilities that are not available with conventional antibody technologies. Unlike hybridoma-derived antibodies, recombinant antibodies can be reformatted to a different species, isotype or subtype. This opens up the possibility of switching antibodies into a more preferable format for in vitro or in vivo use.

Although the antibody may originate from the immunisation of an animal, the manufacturing process is entirely animal-free. This alleviates animal welfare concerns associated with traditional monoclonal antibody manufacturing - specifically ascites production from hybridomas. In addition, the development of high-yielding mammalian expression systems enables the production of large quantities of recombinant antibody in a short-time period.


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