Importance of Cell line in Biosimilar Development

The high cost and limited access to biotherapeutics or biologics are the major reason behind the growth of the biosimilar market in recent times. Since biosimilars are similar to the reference biologics in terms of pharmaceutical quality, safety and efficacy, they can provide economical alternatives to biologics. Although the cost of manufacturing and licensing a biosimilar is generally lower as compared to biologics, still it is very high compared to that of traditional small molecule generics. Reducing the manufacturing cost of biosimilars has become a great challenge for the pharma industry. One of the most important things to take care of during biosimilar product development is the choice of the cell line used, as recombinant biosimilars are generally produced on cell lines and the choice of apt cell lines can lower the cost of the biosimilar.

Cell lines in Biosimilar Development

The development of rapid and low-cost cell lines can be a major step in reducing the cost of biosimilars. Generally, the information about cell lines remains a trade secret as the product remains the property of the originator and the other companies need to undergo several steps to ensure that their product is clinically similar to that of the originator. A recent proposal for reducing the manufacturing price of the cell lines suggested that if the originator could share the details of the development process with the regulators that other manufacturers can access to reduce the cost of cell line development that can positively affect the manufacturing cost of the biosimilars where the cell lines are used. Cell line engineering can also reduce the cost of manufacturing. A combination of host cell clone selection and vector design along with site-specific integration into the host cell’s genome can solve the problem of cell line instability and can further curb the manufacturing cost.

Cell Lines and Biosimilars by Abeomics

Abeomics have a wide range of reporter and stable cell lines that can help accelerate the biosimilar development process. Abeomics’ proprietary Reporter Cell Lines provide the most advanced system available for screening STATs (STAT1, STAT3, STAT4, STAT5, STAT6), Treg, Th17, TLR, DC-SIGN, Tim-1, and inflammatory pathway mediators. New and unique Leeporter™ Stable Reporter Cell lines include target promoters or upstream response elements for TLRs/RLRs, GPCR, RORs, IL-17A, IL-8, IL-6, p53, Nrf2, Wnt, STAT-1, -3, -4 and -5, NFAT, NF-kB, and more, which drive Renilla Luciferase reporter gene expression. Stable Cell Lines are essential tools for protein production, target validation, and functional assays. Abeomics portfolio of stable cell lines includes molecules involved in immune modulation, such as PD-1 cell line, PD-L1 cell line, PD-L2 cell line, CTLA-4 Cell line, ICOS and ICOSL Cell line, TIM3 cell line, Vista cell line, etc.

Abeomics offers a range of Biosimilar Recombinant Antibodies using the same variable region sequence as the therapeutic antibody. You can check our biosimilar antibodies.