Expert view: Biologics driving innovation in LC-MS analytical chemistry
Over the last few years, biologics have continued to make up an increasing proportion of biopharmaceutical sales and pipeline candidates. Cory E Muraco and Wayne Way discuss current trends in biologics analysis.
BIOLOGICS NOW account for more than half of the top-selling drugs by revenue and 2018 saw a record 17 biologics license application (BLA) approvals while the five-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 pre-clinical and clinical development. Currently, most global pharmaceutical companies’ pipelines consist of 20-40 percent biologics, but a majority biologics pipeline is expected this decade.
Relative to synthetic small molecule therapeutics, the manufacturing process for biologics is far more complicated and requires the use of more intense characterisation, from early development through production and QA/QC to ensure safety and effectiveness.