Evolving Analytical Technology Unravels Protein Characteristics
Mass spectrometry and automation are growing in importance for protein characterization, but further improvements are still needed.
Overcoming Vaccine Development Challenges
Vaccine development is inherently challenging; however, in light of the COVID-19 pandemic, innovations have been prioritized, leading to accelerated development processes.
Recombinant Supplements Offer Lower Risk of Cell Culture Contamination
Demand for recombinant microorganism-based cell culture supplements is rising on the back of lower contamination risk.
Moving Closer to End-to-End Continuous Bioprocessing
As downstream bioprocessing improvements continue, efforts are underway to integrate downstream processes into continuous operations.
The Ins and Outs of Syringe Inspection
A best practices approach to pharma’s most challenging-to-inspect container.
Getting to the Root of the Matter for Bio/Pharma Quality Issues
Bio/pharma can learn ways to prevent recurring events and ineffective CAPA from the nuclear power sector.
Packaging Considerations for Clinical Trial Materials
Packaging materials, kit design, and cold-chain handling should be optimized for each study.
FDA and Industry Move to Renew New Drug User Fee Programs
Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.
Moving Into the Next Phase
As face masks start to come off, bio/pharma’s COVID-19 battle goes on.
Computerized System Descriptions–How Hard Can It Be?
System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.
