Pharmaceutical supply chains may grow less efficient and less risk prone as US government gets more involved to ensure availability of pandemic and essential medicines. But what about pediatric oncology medicines and other treatments that save lives even though they may not be considered essential?

Benoit Opsomer, vice-president and head of bioprocessing, Asia Pacific, Merck Life Science, explains how recent targeted CDMO buyouts put the German group in pole position with services across the mRNA value chain, even as it supports global players such as BioNTech. Striking multi-country expansion of manufacturing footprint, including in China, is also underway amid rising demand for biopharma single-use assemblies.

CBER Director Peter Marks said more sophisticated manufacturing expected in the next decade could lead to questions about whether gene therapies should be regulated by his center or CDRH.

The European Medicines Agency’s newly established Quality Innovation Expert Group will focus on innovative pharmaceutical manufacturing approaches, starting with continuous manufacturing for biologicals and end-to-end processes, and decentralized manufacturing.