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Article FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies. By Cynthia A. Challener Ibreakstock/Shutterstock.co…

Article Exotoxin Clearance from mAb Samples in a Two-Step Chromatography Process
A heat-stable exotoxin can remain as a contaminant of a drug substance throughout the whole manufacturing process, with the risk of adversely affecting patients’ health. One such toxin is cereulide …

Article 3rd BioProcessing Asia Preview: Q&A with John Curling
The 3rd BioProcessing Asia conference will take place November 12-15, 2018 on Langkawi, Malaysia. This week, Bioprocess Development Forum talks with John Curling, Conference Chair, about the upcomin…

Article Process Development: What May Lie Ahead in 2018?
2018 is shaping up to be an interesting year in the world of biopharmaceuticals. What have 2017 developments taught us, and what may lie ahead for biopharmaceutical drug developers and process engin…

Article What's in Your SOP?
What’s in Your SOP? SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates. …

Article Transformative Medicines Challenge FDA and Manufacturers
Transformative Medicines Challenge FDA and Manufacturers New gene therapies and combination products require innovative regulatory approaches. By Jill Wechsler …

Article Reliability Rooms and the Move to Proactive Supply Chain Management
Reliability Rooms and the Move to Proactive Supply Chain Management Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict tren…

Article What You Need to Know about Continuous Processing
There is a lot of interest around continuous biomanufacturing, and it is expected to have a significant impact on the biomanufacturing industry over the next few years. Continuous processing can hel…

Article Prepare for an FDA Bioburden Inspection
Even with effective prevention, bioburden incidents can occur. A best-practices response will not only help you be prepared for any upcoming FDA inspection, it may also yield valuable insights to help…

Article Performance of Single-Use Xcellerex™ XDR‑500 MO and XDR‑50 MO Stirred-Tank Fermentor Systems
This application note describes the performance of the XDR‑500 MO fermentor system in comparison with the XDR‑50 MO fermentor. Domain antibody production in E. coli was used as the model process. …

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