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Naji, M. |
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Motta, Antonella |
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Aletan, Dirar |
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Mohamed, Tarek |
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Ertürk, Emre |
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Taccardi, Nicola |
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Kononenko, Denys |
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Petrov, R. H. | Madrid |
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Alshaaer, Mazen | Brussels |
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Bih, L. |
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Casati, R. |
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Muller, Hermance |
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Kočí, Jan | Prague |
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Šuljagić, Marija |
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Kalteremidou, Kalliopi-Artemi | Brussels |
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Azam, Siraj |
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Ospanova, Alyiya |
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Blanpain, Bart |
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Ali, M. A. |
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Popa, V. |
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Rančić, M. |
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Ollier, Nadège |
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Azevedo, Nuno Monteiro |
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Landes, Michael |
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Rignanese, Gian-Marco |
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Neubauer, Peter
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report
Process analytical technology (PAT) needs and applications in the bioprocess industry
Abstract
Process analytical technologies have been applied tomanufacturing processes (pulp and paper, chemical andpetroleum) for decades. Recently, the US Food and DrugAdministration (FDA) has, however, re-defined the phraseand implemented it into an initiative focusing onimproving several aspects of the pharmaceutical industry.The European Agency for the Evaluation of MedicinalProducts (EMEA), has also been active and formed a PATteam in 2003. The PAT initiative was initially intendedfor traditional pharmaceutical manufacturers, but theFDA's PAT guidance now clearly states that it applies toall manufacturers of human and veterinary drug products,as well as biologics regulated by the FDA's Center forDrug Evaluation and Research (CDER) and the Center forVeterinary Medicine (CVM). Basically, PAT involves afundamental shift from testing the quality of thefinished drug product, to building quality into productsby testing at several intermediate steps. It specificallyrequires that quantifiable, causal, and predictiverelationships be established amongst raw materials, themanufacturing process, and final product quality. It isbelieved that PAT may not bring dramatic changesovernight, but years from now, it may be seen as aninitiative that helped foster a period of innovation,efficiency, and expansion for the biopharmaceuticalindustry. In this report, the impact and potentialeffects of PAT on the biotechnological production ofpharmaceuticals is assessed. Hence, we define BioPAT asprocess analytical technologies applied throughoutdevelopment, scale-up and commercial scalebioprocess-based production of drug substances. In thisreport, we will focus on what PAT means in practice forthe biotechnological manufacture of pharmaceuticals.Besides a regulatory examination, the monitoring methodsand technologies available are thoroughly surveyed. Thesefacts are then reflected against the needs for monitoringin bioprocess-based pharmaceutical production.