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The Use of Amplified ATP Bioluminescence for Rapid Sterility Testing of Drug Product Formulations
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PDA Journal of Pharmaceutical Science and Technology September 2023, 77 (5) 402-411; DOI: https://doi.org/10.5731/pdajpst.2022.012762
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Multisite Qualification of an Automated Incubator and Colony Counter for Environmental and Bioburden Applications in Pharmaceutical Microbiology
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A Quality by Design Approach to Microbial Retention Validation
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PDA Journal of Pharmaceutical Science and Technology January 2023, 77 (1) 18-26; DOI: https://doi.org/10.5731/pdajpst.2022.012739
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Stability Evaluation of Hydrogen Peroxide Uptake Samples from Monoclonal Antibody Drug Product Aseptically Filled in Vapor Phase Hydrogen Peroxide-Sanitized Barrier Systems: A Case Study
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PDA Journal of Pharmaceutical Science and Technology May 2019, 73 (3) 285-291; DOI: https://doi.org/10.5731/pdajpst.2018.009340
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A Case Study to Address a Gap in the Device-to-Vial Interface Stopper Push-in by Chemo Spikes
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Development of a Premium Quality Plasma-derived IVIg (IQYMUNE^®) Utilizing the Principles of Quality by Design—A Worked-through Case Study
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A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016
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PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 62-72; DOI: https://doi.org/10.5731/pdajpst.2016.007252
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Revision of Viable Environmental Monitoring in a Development Pilot Plant Based on Quality Risk Assessment: A Case Study
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PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 234-244; DOI: https://doi.org/10.5731/pdajpst.2016.007096
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Air-Water Binary Gas Integrity Test for Sterilizing and Virus Filters
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Investigation of Air–Liquid Interface Rings in Buffer Preparation Vessels: the Role of Slip Agents
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Parenteral Drug Association, Inc.