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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…

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...

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…