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Industry Proponents Make the Case for Continuous Manufacturing

This article was originally published in The Gold Sheet

Executive Summary

Energy, space and API savings more than make up for the cost of switching from batch to continuous manufacturing methods, proponents say. So why not take a chance on it?

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Some regulators are wrongly using monographs rather than a biosimilarity exercise to show comparability of a biosimilar with its reference product, it was suggested at the European Pharmacopoiea’s latest conference. Also discussed were issues such as how to align the PhEur with the new ICH guideline on elemental impurities, and how advances in technology are being dealt with.

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