A New View on Quality Control?
COVID-19 created challenges for quality control departments. How have the lessons learned from the pandemic influenced the way companies use technology to perform quality-control procedures?
Research Advances are Improving ADC Development
ADC development is on a positive trajectory from a deeper understanding of therapeutic mechanisms and technological advances.
Perfusion Cell Culture is Gaining Ground Upstream
The adoption of perfusion cell culture continues to advance with the help of PAT tools.
Analytics Advances for Optimizing Downstream Processes
Surrogate analytics are no longer sufficient, as simple inexpensive real-time analytics are urgently needed for high value products.
Visual Inspection: Seeing Room for Improvement?
Automatic visual inspection machines and artificial intelligence highlight inspection deficits for parenteral containers and units.
Redefining Contamination Control for CGTs
The need for improved analytics grows.
Single-Use Systems Enhance Flexibility
Disposable equipment components find use in small-volume aseptic biopharmaceutical manufacturing.
Considering a Coating Technology as an Alternative to Silicone Oil
A coating technology for a staked needle prefillable syringe reduces the potential risks associated with silicone oil as a lubricant.
Emergence of India as a Global Manufacturing Hub for Biosimilars
The biopharmaceutical landscape of India is transforming in terms of regulatory policies, product development, and affordability.
Biopharma Industry is Seeing Merit in Early Preclinical Strategies
The biopharma industry is seeing more merit in strategizing clinical and commercial drug development as early as the preclinical phase.
Pandemic Alters FDA Inspections and Quality Oversight
New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.
Can We Agree on Conferences?
The Remote Audit–A Tongue-in-Cheek Memo
Siegfried Schmitt, vice president, Technical at Parexel, comments on the new paradigm of remote audits.
