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Activity Number:
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77
- Contributed Poster Presentations: Biopharmaceutical Section
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Type:
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Contributed
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Date/Time:
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Monday, August 3, 2020 : 10:00 AM to 2:00 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #310924
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Title:
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Just in Time, on the Job Statistics Training for Biologics Process Characterization
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Author(s):
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Melissa Matzke* and Seth Clark and Richard K. Burdick and David Christopher
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Companies:
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Merck & Co., Inc. and Merck & Co., Inc. and Burdick Statistical Consulting, LLC and Merck & Co., Inc.
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Keywords:
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CMC;
Biologics;
Process Characterization;
Design of Experiments;
Bioprocessing;
Teaching
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Abstract:
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In today’s pharmaceutical business climate of increasingly accelerated program time lines, certain aspects of chemistry, manufacturing and controls (CMC) development have the potential to be rate-limiting on the critical path from successful clinical results to a viable commercial product. Process characterization is critical to commercial success but can be riddled with unpredictable delays and limited resource. Just in time, on the job (JITOTJ) statistics training allows limited resourced statistics teams to fully engage business critical process characterization projects by enabling scientists and engineers to implement a fully vetted statistical experimental design, analysis and reporting plan.
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Authors who are presenting talks have a * after their name.
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