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Panel discussion on CMC for vaccines: "Responding in Time: Dealing with Predictable and Unpredictable"
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: 2017 Vaccines Bioprocess Development & Commercialization Workshop, MIT Center for Biomedical Innovation (CBI), Issue MIT Center for Biomedical Innovation (C ...
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.
times and stages, good communication between company and OMCL is imperative. Once the method validation has been successfully completed and the company has obtained its MA, first commercial batches can be ...
Implementation over the past 20 years of the 3R's principle for batch release at the Scientific Institute of Public Health, Belgium (IPH).
Tetanus time toxicity use vaccine vaccines VALIDATION Validation study Weight Weight gain Weight-gain world Abstract: For the batch release of vaccines on the European market, a limited number of quality ...