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European Pharmaceutical Review Issue 1 2019

22 February 2019 | By

In this issue we look at the challenges of shipping temperature-controlled products, the potential use of blockchain for pharma, and using MALDI-TOF for identification of peptides in suspected illegal medicinal products. The edition also includes articles on aseptic containment, legal advice on licensing negotiations and an In-Depth Focus article from…

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Expert View: What ADC evolution means for manufacturing

19 December 2018 | By ,

The evolution of antibody-drug conjugates (ADCs) is a spectacular example of how global research can sculpt a new technology. Years of molecular and cell biology, conjugation chemistry and immunology progress has enabled a cytotoxic agent paired with a tumour-specifi c antibody to become mainstream cancer therapy.1 Today, advances continue, explains…

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Spotlight on… Single use

10 September 2018 | By

In this Spotlight on Single Use, David Beattie, Vice President BioProcessing R&D, Merck explains the mode of operation and benefits of its Pellicon® Capsules...

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Understanding current CFR 21.11 and data integrity requirements

8 August 2018 | By SUEZ

The US FDA and European Commission have defined regulations relating to the submission of electronic records in lieu of paper documents, for submission, inspection, and archiving purposes. When ageing analytical equipment is to be replaced 21CFR Part 11 and EU Annex 11 are also topics of discussion. Common questions from…