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European Pharmaceutical Review Issue 5 2020

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 magazine 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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