The use of recombinant antibodies has increased in biomedical research in recent years. An increased understanding of antigen specificity and manufacturing practices has vaulted recombinant antibodies into the spotlight. Whereas traditional antibodies are produced much in the same way that our bodies create antibodies, recombinant antibodies can be manufactured using synthetic genes expressed in an in vitro mammalian cell line, bypassing the need for animal systems. By manufacturing antibodies in mammalian cell lines, many unique advantages become present.
Reproducibility and Control
Quality of antibodies, their specificity, is crucial for reliability and reproducibility of results in scientific research. Recombinant antibodies offer more reproducibility and control. Variability between different batches of antibodies produced in animals can be caused by many factors, including individual animal health, immune status, efficiency of immunization program and so on. Read publication in Nature "Finding the right antibody for the job" to find out why variability is almost “the nature of the business”. Recombinant antibodies, on the other hand, are biologically defined by a known DNA sequence, and an identical antibody is produced in each manufacturing batch. There is no risk of genetic drift associated with hybridoma-based production processes and no variability due to additional light chains that are often present in hybridomas. Recombinant antibodies produced in vitro offer high reliability and reproducibility of results. As such, they are a much better choice for use in ELISA, IHC, Western Blotting and other applications, especially when high number of samples has to be analized.
It has been estimated that less than 50% of commercially available antibodies routinely used in research laboratories exclusively recognize their specific target antigens [Berglund, L. et al. Mol. Cell Proteomics 7, 2019–2027 (2008)]. Authors of another study [Begley, C. G. & Ellis, L. M. Nature 483, 531–533 (2012)] were able to reproduce the results of only 6 of 53 (11%!) published preclinical research papers. The need for reliable antibodies has recently been strongly advocated by a publication in Nature magazine [Bradbury and Pluckthun +110 co-signatories] "Reproducibility: Standardize antibodies used in reserach". According to this publication, the estimated cost of lost time, money and materials is $350 million per year in the USA only. The authors argue that if all the antibodies used in research were recombinant, scientists around the world would be able to use the same well characterized reagents, producing reliable results, saving time and money. They make a prediction that “the uncharacterized, unsequenced antibody will become obsolete”.
The manufacturing and purification processes are strictly controlled, resulting in unparalleled purity and ultra-low batch-to-batch variability. They are expressed in a chemically defined serum-free system that eliminates contamination with components of serum (e.g., BSA and IgGs, leading to a product with very high purity (>98%).
Reformatting and Engineering
Importantly, animal-derived antibodies often cause immune reactions in patients, limiting their use as clinical therapies. They must be “humanized” before they can be used in people. This process of antibody altering, or “humanization” may affect antibody performance and cause side-effects. Recombinant antibodies can be easily converted into different species, different isotypes or subtypes. They can be engineered at the genetic level enabling the 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. For further information on this service contact us.
Recombinant antibody production does not require use of animals, eliminating ethical and animal welfare concerns. Some countries prohibit the use of animals for ascites production (one of the stage in mouse monoclonal antibody production) to reduce animal use and suffering.
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