The Current Landscape of Monoclonal Antibody Production

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Since the advent of the first licensed monoclonal antibody (mAb) product in 1986, bioprocessing technologies have undergone a remarkable evolution. Initial mAb production methods were notably inefficient, yielding titers below 1 g/L. However, over the past three decades, upstream bioprocessing and downstream bioprocessing have witnessed substantial advancements. Enhanced cell lines, optimized culture media, intensified processing techniques, and modernized purification platforms have collectively propelled mAb titers beyond 1 g/L. As the demand for mAbs continues to surge, innovations and more precise indicators of product quality and process efficiency are imperative to meet market requirements for accelerated production, heightened productivity, and cost-effectiveness.

This article provides an in-depth history of the bioprocessing industry and introduces the HaLCon Protein Analyzer as an invaluable solution for measuring the most essential quality indicator for mAb production: protein concentration. The accuracy of HPLC combined with unsurpassed speed and ease of use are among the many reasons leading CDMOs and biopharma companies have embraced HaLCon, thus shaping the landscape of bioprocess technology while saving time and money.