BioPharm International-05-01-2021

Mass spectrometry and automation are growing in importance for protein characterization, but further improvements are still needed.

Vaccine development is inherently challenging; however, in light of the COVID-19 pandemic, innovations have been prioritized, leading to accelerated development processes.

Demand for recombinant microorganism-based cell culture supplements is rising on the back of lower contamination risk.

As downstream bioprocessing improvements continue, efforts are underway to integrate downstream processes into continuous operations.

A best practices approach to pharma’s most challenging-to-inspect container.

Bio/pharma can learn ways to prevent recurring events and ineffective CAPA from the nuclear power sector.

Packaging materials, kit design, and cold-chain handling should be optimized for each study.

Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.

As face masks start to come off, bio/pharma’s COVID-19 battle goes on.

System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.