Journal Articles

The rapid global response to the COVID-19 pandemic showed how remarkably fast vaccine development can be with a coordinated effort from biopharmaceutical companies, government organizations, regulatory agencies, and public institutions. Although some of the world’s most prolific diseases are more complex than COVID-19 coronavirus, growing infrastructural and financial support are enabling scientists to make breakthroughs in diseases that seemed insurmountable only a decade ago in underserved regions around the world.

Quality control (QC) is a fundamental aspect for assuring the safety and efficacy of medicinal products. Testing of drug substances (DSs) and final drug products (DPs) is performed at intermediate manufacturing stages to confirm that they meet established specifications as defined in a marketing authorization. This does not differ for advanced-therapy medicinal products (ATMPs).

Assay development doesn’t end with a validated analytical method. Changes are made as a biopharmaceutical product continues through development. Often that progress includes transfer from the original laboratory to another. Whether a project is outsourced or scaled up in house, analytical methods such as bioassays must be transferred to new laboratories, with different personnel and often different equipment setups.

A webinar hosted by Biopharma Excellence featured an in-depth discussion on the ways that updated guidelines, a reduction in clinical efficacy testing, and biomarker analyses can have on the efficiency of biosimilar development.