The road to drug approval is a long and bumpy one. It’s estimated that a drug takes at least 10 years to make the journey from discovery to the market. The overwhelming majority of drugs will not complete the journey. Around five in every 5,000 drugs that enter preclinical testing will progress to human testing; of those that do make it to man on average only one will go on to be approved. Overall this makes the chance of any new drug being approved a meagre 1 in 5,000.
Approval of new drugs is controlled by various regulatory agencies. The Food and Drug Administration (FDA) and the European Medicines Agency govern this process in the U.S. and Europe, respectively. The drug development and the drug approval processes involve a number of key steps.
There is an extensive and increasing development pipeline for monoclonal antibody therapeutics, which combined with advances in automation in upstream processes, such as cell culture and purification process development, is driving a requirement for innovative analytical tools in order to deliver greater productivity.
Recombinant monoclonal antibodies can be highly heterogeneous due to modifications such as sialylation, deamidation and C-terminal lysine truncation. During development and production of these products, it is essential to detect, characterize, and quantify impurities as well as structural variants and modifications, and to monitor product stability. This is key to demonstrating their safety and efficacy!
In the fast-paced drug development environment, a generic platform approach which saves time in method development and facilitates method transfer for a wide range of monoclonal antibody charge variants, is a must.
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A pH buffer gradient kit has been developed which facilitates the reproducible generation of a linear pH gradient from pH 5.6 to pH 10.2 which simplifies charge variant separation and enables high resolution, fast and rugged monoclonal antibody charge variant analysis. Sounds great, right?! It gets better. At the moment you can enter a competition to win a free CX-1 pH buffer kit or simply take advantage of a 25% discount. All the more reason to try for yourself!
Enter the competition to win a free CX-1 pH Gradient Buffer kit and also receive a 25% discount for all kit purchases throughout 2017.
Learn how the kits can improve your workflow in this 5 minute animation:
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By employing new technologies, you can more efficiently deliver breakthrough medicines to enable patients to live longer, healthier, happier lives.