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PROCESS ANALYTICAL TECHNOLOGY IMPLEMENTATION

This article was originally published in The Gold Sheet

Executive Summary

...is driving pharmaceutical manufacturers to realign their organizational structures to handle the cross-functional demands involved. Biogen Idec and Sanofi-Aventis are among those firms who have developed integrative team approaches to building the momentum needed for bringing the projects to fruition. Close communication with FDA is proving to be an important support mechanism for working through the many challenges. Like FDA, the EU’s EMEA also has put a PAT initiative in place to help facilitate implementation. Although the attention has been on big pharma, firms whose lifeblood is efficiency such as generic product and contract manufacturers may become PAT pathfinders. [A presentation by Sanofi-Aventis’ Fischer on his firm’s groundbreaking PAT pilot project and comparability protocol is included. Also included are discussions by Xcellerex’s Galliher on PAT in biomanufacturing’s future and by Pfizer’s Migliaccio on the evolution of manufacturing science and PAT applications]

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