Recombinant Protein Biosimilar Stable Cell Lines
A similar biological medicinal product, termed biosimilar, is a biologic agent that has high similarity in terms of quality, safety, and efficacy to an authorized reference medicine. Biological medicines are larger, more complex as well as less stable than general small-molecule drugs. The variability inherent in the production of biological drugs leads to end products that are similar, but not fully identical to the reference medicine they seek to replicate. Therefore, the definition of biosimilar refers to a biological drug produced from a different cell line, master cell bank, and diverse procedure. In Creative Biolabs, we can provide custom services to establish a broad range of stable cell lines for the development and manufacture of biosimilars to suit clients’ needs.
Fig.1 Biosimilar development pipeline: key manufacturers, country, and the number of biosimilar agents categorized by originator and therapy area. (Jacobs, et al., 2016)
The recombinant protein is a form of protein product encoded by a recombinant DNA, which has been cloned in an expression system to support the expression of exogenous genes. The production of recombinant proteins is essential for both the structural determination of drug targets and the development of new protein drugs. As we knew, the recombinant protein-based medicines produced by rDNA technology have been approved in clinical practice since the early 1980s. These drugs as original biopharmaceuticals significantly contributed to the therapy of severe degenerative and metabolic diseases. The recent data protection or patent-expiration of them creates opportunities for the development of original biopharmaceuticals replications with similar biological activities (biosimilars). These new copy versions are expected to meet global demands, promote market competition, and maintain the incentives for innovation.
Fig.2 Scheme of production of recombinant proteins and the analysis of the products of each. (Morbioli, et al., 2016)
The recombinant protein has increasingly become mainstays of treatment for some diseases and its production plays a major role in drug development. The arrival of biosimilars for a variety of key recombinant biologics has the potential to provide cost savings to healthcare systems and expand underlying access to important medicines. The report indicated that recombinant proteins in humans are often immunogenic in animals. As such, it should be possible to develop a generic recombinant human protein using a similar cellular source. In Creative Biolabs, therapeutic recombinant proteins have been engineered in living cell lines or transgenic organisms. We are pleased to offer one-step, custom-oriented services regarding biosimilars, especially recombinant protein drugs, through stable cell lines for time-saving and cost-effective research.
References:
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Jacobs, I.; et al. Monoclonal antibody and fusion protein biosimilars across therapeutic areas: A systematic review of published evidence. BioDrugs. 2016, 30(6): 489-523.
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Morbioli, G.G; et al. Recombinant drugs-on-a-chip: The usage of capillary electrophoresis and trends in miniaturized systems - A review. Anal Chim Acta. 2016, 935: 44-57.
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