Issue 5, 2018
In this issue: LC-MS multi-attribute methods for the characterising and QC testing therapeutics, integrating data from Quality Control and Production to enable fast and informed decisions, and Solid-state NMR spectroscopy: using freeze drying to predict the stability of biological products.
In this issue:
- Mutagenic Impurities: a done deal?
Dave Elder, JPAG member and David P Elder Consultancy
- REGULATORY INSIGHT: Brexit – will all the medicines get to the patients?
Paul Gershlick, Partner and Head of Pharma & Life Sciences
- MICROBIOLOGY: Learning from clinical microbiologists – culturomics and metagenomics
Jeanne Moldenhauer Excellent Pharma Consulting, Inc. Mundelein, IL
- LAB INFORMATICS: Integrating data from QC and Production to enable fast, informed decisions
Sinéad Cowman, EU Business Development Manager, Informatics, Lonza
- SPECTROSCOPY: NIR inspection of each tablet that exits a tablet press
Ryan Gosselin, Department of Chemical and Biotechnological Engineering, Pfizer Industrial Research Chair, Université de Sherbrooke, Sherbrooke, Québec, Canada
- FREEZE DRYING: Solid-state NMR spectroscopy: predicting stability in lyophilised biological products
Ashley Lay and Eric J. Munson, University of Kentucky and Yongchao Su, Merck & Co.
- GUIDE TO SERIES: Outsourcing
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