Monoclonal antibodies (mAbs) have found widespread application because they can help restore, enhance or mimic the immune system’s ability to attack cells and viruses. Some mAbs are designed to act as a targeted therapy. Others can act as an immunotherapy because they make the immune system respond better by allowing the body to find and attack cancer cells. Since the first US FDA-approved monoclonal antibody in 1986, mAbs have become an established treatment for cancer and autoimmune diseases as well as for infectious diseases such respiratory syncytial virus (RSV) and as COVID-19.
A mAb treatment typically requires large doses administered intravenously over long treatment times, up to several years. This has direct implications for manufacturing capacity and costs of goods.
When developing cells lines for mAb therapeutics, a tried and tested platform is essential for ensuring:
For more than 20 years, Selexis has been at the forefront of helping the biopharmaceutical industry advance life-saving mAb therapeutics into the clinic and to the market. With 122 SUREtechnology generated mAbs in pre- and clinical development and five approved mAb therapeutics*, Selexis’ SUREtechnology Platform™ is the go-to cell line platform for monoclonal antibody production. Utilization of proprietary codon optimization and SUREtech Vectors™ ensures scientists can establish stable and high-performance research cell banks (RCBs) with titers reaching up to 10g/L in a fed-batch production process. Selexis’ modular approach assures predictability and consistency. Analytics are introduced early in the cell line development process to ensure only cell lines with the best quality attributes progress through the subcloning process to the final RCB.