Special Edition Pharma Analysis & QC

Dear Reader,

Over the past several years, biologics have continued to make up an increasing proportion of biopharmaceutical sales and pipeline candidates. Biologics now account for more than half of the top selling drugs by revenue. In fact, 2018 saw a record 17 biologics license application (BLA) approvals and the 5-year annual average has more than doubled over the last decade. This trend is expected to continue for the foreseeable future with many different modalities of biologics in preclinical and clinical development. Currently, most global pharmaceutical companies’ pipelines consist of 20-40% biologics; the tipping point to a majority biologics pipeline is expected this decade. But relative to synthetic small molecule therapeutics, the manufacturing process for biologics is far more complicated and requires the use of more intense characterization, from even the earliest stages of development through production and QA/QC to ensure safety and effectiveness. While liquid chromatography/mass spectrometry (LC/MS) has always had an important role in small molecule pre-clinical animal studies and in human clinical studies, expanded use is realized both upstream into target identification and downstream into manufacturing and QC release testing with biologics.