Search results for " analytical" in Articles / App Notes
Article
Q&A with Industry Leaders: Rita Peters
At Pittcon 2014, the annual exhibition for analytical instruments and technologies, major instrument manufacturers announced product introductions specific to biologic drug research and development. T…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Control strategies such as process analytical technology (PAT) may be allowed for better control, a reduced NOR and, therefore, reduced variation relative to its PAR. A lower likelihood (occurrence) o…
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Outsourcing Trends in Biopharmaceutical Manufacturing
The author highlights the top 10 outsourcing trends revealed during a survey of biopharmaceutical manufacturers.
The biopharmaceutical industry is changing the way it manufactures. According to …
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State of Quality and Compliance in the Biopharmaceutical Industry
Among these initiatives are the Pharmaceutical cGMPs for the 21st Century, process analytical technology (PAT), quality by design (QbD), and harmonization of international standards and guidelines.
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Operational Excellence: More Than Just Process Improvement
Deviation reports were made the responsibility of a single investigator with specific analytical and investigation reporting skills. The reports were then designed to connect the event and its root ca…
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Essentials in Establishing and Using Design Space
This includes the variation from the model (RSquare) plus the variation due to other factors and the variation from the analytical method. Variation due to stability may also be included as a noise fa…
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The Development and Application of a Monoclonal Antibody Purification Platform
A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.
The following ar…
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Advancing QbD in the EU
In 2003, EMA set up a team to back activities in process analytical technology (PAT) in the EU. The agency has seen its PAT team as a key element in the implementation of QbD by encouraging process un…