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2 min read

The promise of biosimilars starts with a proven manufacturing cell line

Over the past 30 years, biologic therapeutics have significantly transformed treatment options for millions of individuals who face a range of life-threatening diseases. Not only have biologics improved outcomes, but in many cases, they have resulted in fewer side effects and have fostered a better quality of life compared with earlier therapies. As original brand-name (innovator) biologic drugs go off patent, biosimilars represent an opportunity to develop lower-cost options of these important medicines. The U.S. and European regulatory agencies call for biosimilars to meet very stringent similarity requirements when compared with innovator drugs. Biologics are complex, high-molecular-weight molecules that are generated from living cells that change their behavior in response to environmental pressures. Small variabilities in feed strategy, cell line stability or even cell line generation can have a significant impact on the final product, such as the glycan profile. As a result, generating biosimilars with demonstrable structural equivalence to that of innovator drugs is very challenging.

Like small molecule generics, the value proposition of biosimilars is a reduction in the cost of goods. Therefore, a biosimilar manufacturing cell line must generate high quantities of product, stably over time under the high-cell-density conditions in large bioreactors. Furthermore, this product must have equivalent post-translational modifications, like glycosylation, to the originator product. Once a cell line is established, optimizing the manufacturing scale-up for the biosimilar requires tight control and detailed analytics to ensure the composition profile of the biosimilar fits within the originator’s specifications.

Selexis has a long history of success in efficiently generating high-quality and high-producing biosimilar manufacturing cell lines and has multiple biosimilar products on the market designed to treat conditions ranging from inflammatory disease and genetic disorders to cancer. Its most recent commercial product is for the treatment of persistent atopic bronchial asthma and resistant chronic idiopathic urticaria.

The company’s success is built upon its SUREtechnology Platform and SURE CHO-M Cell Line (CHO-M). Selexis has comprehensively characterized the CHO-M’s genome and transcriptome and can modify its activity and productivity using its SURE CHO-Mplus Libraries, yielding a versatile CHO cell line development platform that is able to address almost any issue associated with biosimilar development. The Selexis media and feed strategy readily transfers to any manufacturing partner and has proven to be a good starting point for biosimilar upstream development by the company’s contract manufacturing partners. Recently, Selexis announced the signing of its fourth and fifth commercial licenses with Turgut Biopharmaceuticals for biosimilar products.

As the demand for biosimilars has grown, Selexis has been able to quickly support partners’ biosimilar programs on a global scale by generating cell lines producing clinic-ready biosimilar material. Biosimilars aim to expand patient access to new treatment options and their introduction starts with a proven manufacturing cell line. Selexis is proud to work with our partners and play a role in transforming the lives of patients.

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