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A biosimilar is a biologic medical product that is very similar to an original product, also known as a reference product, that is approved by FDA (Food and Drug Administration). Compared with the reference products, biosimilars are highly similar to the reference product in terms of safety, purity and potency, but with significantly reduced costs. The pressure of high healthcare costs associated with the use of biologics have created a significantly high demand for biosimilars.
Stable cell line development is one of the most important steps for biosimilar development. Creative Biogene has years of experience in stable cell line development. Our scientists have successfully expressed biologics including full antibodies, antibody fragments, bispecific antibodies, fusion proteins and growth factors. With the goal of accelerating the process of biosimilar drug development, at Creative Biogene, multiple biosimilar stable cell lines have been developed and have shown high performance in yield. In addition, more biosimilar stable cell lines are under development and will be available for sale soon.
Biosimilars are medicines that are highly similar to, but not identical to, a biological reference product. Unlike the production of generic small molecule drugs that are chemically identical, biomanufacturing uses unique cell lines and complex proprietary manufacturing processes that cannot be completely replicated. All biologics possess microscopic heterogeneity, for example in protein isomers or glycosylation patterns. Variations in the manufacturing process mean that even originator biologics may not be 100% identical from production batch to batch. Although recombinant technologies are powerful tools for expressing biotherapeutics, successful manufacturing depends on stable cell lines expressing high protein titers. A critical part of biopharmaceutical development is selecting the right cells to achieve cell productivity, cell line stability, and final product quality.
To improve cell line selection and reduce development time, Creative Biogene has developed multiple biosimilar stable cell lines and demonstrated higher yields.
Applications for biosimilar stable cell lines include:
Case Study 1
The discovery of trastuzumab as an anti-HER2 therapy has significantly improved disease control and survival in patients with HER2+ breast cancer. However, because trastuzumab is considered a complex molecule, production costs are often elevated, which can severely impact health budgets and limit access to treatment for patients living in less developed countries. Recently, trastuzumab stable cell lines have made trastuzumab production easier and more sustainable, allowing the development of biosimilar versions of trastuzumab.
Figure 1. Trastuzumab biosimilars improve patients' accessibility to breast cancer HER2 + treatment. (Peliçário Vargas B, et al., 2022)
Case Study 2
Rapid development and scale-up of biosimilar trastuzumab based on pembrolizumab stable cell line
Figure 2. Analytical evaluation of downstream process (DSP) for screening of process stages and parameters. (Jaffar-Aghaei M, et al., 2022)
Q: What are biosimilars?
A: Biosimilars are biological products that are highly similar to an existing, authorized reference biological product.
Q: How is the development of biosimilars different from that of chemical generics?
A: Biosimilars are highly complex, large-molecule drugs derived from living organisms. They are often proteins or antibodies produced through biotechnological processes. Chemical generics, on the other hand, are simpler, small-molecule drugs with a well-defined chemical structure. The complexity of biosimilars makes their development and evaluation more challenging.
Q: What characteristics must a suitable host cell have for a biosimilar cell line?
A: Some characteristics include high growth rates, genetic stability, and the ability to correctly fold and glycosylate proteins.
Q: What are the advantages of developing biosimilar cell lines?
A: The advantages include improved cost-effectiveness, enhanced productivity and consistency in drug production, and the potential to expand treatment options and increase patient access to biologic drugs.
Q: How do biosimilar cell lines ensure consistent quality characteristics in drug production?
A: By engineering cells to optimize protein production, biosimilar cell lines can produce higher amounts of therapeutically active proteins with consistent quality, reducing batch-to-batch variability and improving patient safety and treatment outcomes.
| Cat.No. | Product Name | Price |
|---|---|---|
| CSC-BS0001 | Rituximab Stable Cell Line - CHO-K1 | Inquiry |
| CSC-BS0002 | Trastuzumab Stable Cell Line - CHO-K1 | Inquiry |
| CSC-BS0003 | Cetuximab Stable Cell Line - CHO-K1 | Inquiry |
| CSC-BS0004 | Nivolumab Stable Cell Line - CHO-K1 | Inquiry |
| CSC-BS0005 | Pembrolizumab Stable Cell Line - CHO-K1 | Inquiry |
| CSC-BS0006 | Adalimumab Stable Cell Line - CHO-K1 | Inquiry |
| CSC-BS0007 | Infliximab Stable Cell Line - CHO-K1 | Inquiry |
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