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?
You may also be interested in...
Pharma Industry Still Not At 'Tipping Point' In Adopting Continuous Manufacturing
Regulators and industry officials agree that despite efforts to spur development of continuous manufacturing, uptake has been slow globally. FDA still is on learning curve and acknowledges a knowledge gap around some of the higher order principles associated with continuous manufacturing.
Poor Biosimilarity Practices, Impurities and New Technologies Debated At European Pharmacopoeia Event
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.
Poor Biosimilarity Practices, Impurities and New Technologies Debated At European Pharmacopoeia Event
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.