Richard Jaenisch explains why NAMs are compressing drug development faster than AI and what FDA's new nonclinical testing rule means for sponsors.
News|Articles|June 3, 2011
Pharmaceutical Technology Europe
- Pharmaceutical Technology Europe-06-01-2011
- Volume 23
- Issue 6
Optimising High-Potency Manufacture
Author(s)Patricia Van Arnum
Effective containment in API and drug-product manufacturing encompasses a variety of process, equipment, and operational issues.
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High-containment manufacturing, whether for an active pharmaceutical ingredient or finished drug product, requires specialized approaches in facility design, equipment selection, and manufacturing processes to achieve the desired levels of containment and minimize operator exposure. As with pharmaceutical manufacturing overall, science- and risk-based approaches to reach those goals serve as a crucial framework for optimizing high-potency manufacturing as well for specific elements in the process.
This article was also published in our US sister publication Pharmaceutical Technology and can be read
Articles in this issue
over 15 years ago
The EMA And EU Expansionover 15 years ago
The Rising Uptake Of Immediate Release And ODT Formulationsover 15 years ago
Table Testing Techniquesover 15 years ago
Celebration And Cinemaover 15 years ago
Newsover 15 years ago
The Influence Of Superdisintegrants On Immediate Releaseover 15 years ago
The Single-Use Technology World Tourover 15 years ago
Annex 11: Progress in EU Computer Systems Guidelinesover 15 years ago
A Comparison of Three Extrusion Systems (Part II)over 15 years ago
New Annex 11: Enabling InnovationAdvertisement
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