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Setting specifications for Biologicals. Points to consider from simple to complex. Case study for viral vectored vaccines.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: 2017 BioMAN Workshop on Setting Specifications for Biotherapeutic Products, BioMAN, Issue BioMAN, ...
Panel discussion on specifications for biologicals
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: 2017 BioMAN Workshop on Setting Specifications for Biotherapeutic Products, BioMAN, Issue BioMAN, ...
Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mind-set of the manufacturer.
to mention some of them. Assay variability and possible changes in analytical methods and specifications during the registration procedure should also be closely monitored. The full method transfer and ...
Implementation over the past 20 years of the 3R's principle for batch release at the Scientific Institute of Public Health, Belgium (IPH).
medicines mice Multiple national need Network ON Order past pertussis ph PRODUCTS public public health Public-health Quality Reduction repeated routine SAFETY situation specific study Test TESTING tests ...