European Pharmaceutical Review Issue 5 2020
Posted: 16 October 2020 | European Pharmaceutical Review | No comments yet
In this issue you can find articles discussing the supply chain implications of Trump’s ‘Buy American’ order, guidance on how to identify and justify starting materials for regulatory approval by both the EMA and FDA, as well as some of the latest developments in oral biologic drug delivery techniques. Also included in the issue is an overview of solid-state NMR spectroscopy for drug substance and drug product analysis and a discussion on how far the world is from being proactive rather than reactive to future pandemics and crises.
Included in Issue 5:
- FORMULATION, DEVELOPMENT & DELIVERY
Science and risk-based specification setting for excipients
Sunil Kumar Nataraj and Bastiaan Dickhoff, DFE Pharma
Kalyan Janjanam, Epic Pharma - FUNGAL IDENTIFICATION
Improving fungal ID options
Sebastien Vacher, CONIDIA - MANUFACTURING, PACKAGING & LOGISTICS
Stepping up metformin production: a case study
Caterina Funaro and Massimo Malavolti, IMA
Scaling up production capacity when the world is waiting
Rod Schregardus, The Access Group - DIGITAL TRANSFORMATION IN THE LAB
How an integrated LIMS platform can transform drug development and manufacturing workflows
William E Weiser, Pharma Services, Thermo Fisher Scientific - QA/QC & ANALYTICAL TECHNIQUES
Primary validation of the growth direct bioburden system and media
Edwin van den Heuvel and Abu Manju, Eindhoven University of Technology
David Jones, Niloufar Parsaei and Jaime Brosseau, Rapid Micro Biosystems - REGULATORY INSIGHT
What the world can learn from the UK’s pharmaceutical industry
Cheryl Teoh, Leyton - BIOPROCESSING & BIOPRODUCTION
A crucial turning point for increasing patient access to ATMPs
Dr Robert Stephen and Dr Jane Hollywood, CMS
Biologics: a leadership journey
Ben Woollard, Five and Co
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