european Pharmaceutical review - 5 Pages

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european Pharmaceutical review

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EPR Cover 611_EPR Cover 29/11/2011 10:46 Page 1 The FDA’s PAT Initiative, past and present Terry McMahon, PAI Partners The future of drug discovery We talk with leaders from Bayer, GlaxoSmithKline, Johnson & Johnson and Pfizer Using miRNA manipulation as an antiviral therapeutic strategy Amy H. Buck and Nouf N. Laqtom, University of Edinburgh

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PAT SUPPLEMENT IMPLEMENTATION OF MODELLING APPROACHES IN THE QbD FRAMEWORK: EXAMPLES FROM THE NOVARTIS EXPERIENCE Dr. Marianna Machin, Dr. Lorenz Liesum and Dr. Antonio Peinado Novartis Pharma AG The fundamental concepts behind the FDA PAT initiative are driving the pharmaceutical industry to put greater emphasis on the scientific understanding of their manufacturing processes, thus focusing its efforts both on ensuring product quality compliance through end product testing, and on understanding the impact of the manufacturing conditions and process variability on the quality attributes. In...

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identification of influential and critical process parameters identification of correlation pattern among the process parameters generation of process signatures relationship between process parameters and quality attributes by multivariate regression analysis After the successful transfer of a product from pilot plant to commercial scale, the available and achieved process understanding needs to be embedded and translated into an appropriate process control strategy. The benefits of using MVDA in this context are: l efficient on-line tool for multivariate FIGURE 1 MSPC model for a...

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For Sartorius PAT is much more than just an expensive sensor integrated in a process. PAT is a risk based strategy for designing, analyzing and controlling manufacturing processes. Case Study II: Review of the historical in-process control data from a cell cultivation process using multivariate data analysis The scope of this work is to improve the understanding and the reduction of the batch to batch variability in terms of antibody yield for a cell cultivation process. Specifically, the upstream manufacturing process (seed and main bioreactor) is discussed herein. All the batches in scope...

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In addition, the inoculation density of cells to the main bioreactor appears to be important and the medium feeding rate should be a function of the actual viable cell density in the main bioreactor phase. Generally, it appears important to maintain the aeration rate at a lower level at the beginning of the culture. All the batches have then been summarised by combining all the process data (both seed “ MVDA is a valid tool to improve the understanding of the process ” and main bioreactor) over time and the DS quality attributes at the batch level (i.e. using a Batch-level Statistical...

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