Issue #4 2016 – Digital edition
In this issue: Regulation, Environmental Monitoring, Drug Delivery; Microbiology, Track & race, Spectroscopy, HPLC, Mass Spectrometry, and much more…
- FOREWORD: EPR health-based exposure limits for cleaning qualification
David P. Elder, JPAG chair and Consultant - REGULATORY INSIGHT: The legal framework applicable to biosimilars in the EU
Hilary Jones, Bristows LLP
- ENVIRONMENTAL MONITORING: IN-DEPTH FOCUS
With articles from R. Vijayakumar, Majmaah University, Tim Sandle, Bio Products Laboratory and Anastasia Petropoulou, University Hospital Bristol’s NHS Foundation Trust - DRUG DELIVERY: Approaches in subcutaneous delivery of monoclonal antibodies
Claus Geiger, Till Bussemer, Tanya Mezhebovsky and Bernardo Perez-Ramirez, Sanofi - MICROBIOLOGY SERIES: Current activities of the USP general chapters
Radhakrishna Tirumalai, PhD, United States Pharmacopeial Convention - TRACK AND TRACE
Including legal analysis from Kathleen M. Sanzo and Jacqueline Berman, Morgan, Lewis & Bockius LLP, and Jacob Gifford Head, Thomas More Chambers - SPECTROSCOPY: IN-DEPTH FOCUS
With contributions from Koen De Smet, Tom Van Den Kerkhof and Anke Prudic, Janssen, and Daniel Markl, Michael T. Ruggiero, and J. Axel Zeitler, University of Cambridge - HPLC: Application of LCMS in small-molecule drug development
Chunang (Christine) Gu, David Russell and Peter Yehl, Genentech - MASS SPECTROMETRY: Characterising therapeutic antibodies and ADCs using mass spectrometry
Ioannis Papayannopoulos, Celldex Therapeutics
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