Search results for "analytical"
Article
Pharma Investments Reflect Key Industry Trends
Bayer Healthcare is also investing $138 million to expand its packaging, logistics, and analytical capabilities at its facility in Beijing, China.
Boehringer Ingelheim: After investing more than $…
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A Q&A With Phil Lester, co-organizer of the HTPD Conference
For the Olympiad, Cytiva created a kit containing a target protein in a crude feedstock along with a variety of chromatography media and suggested analytical methods. The goal is to purify the target …
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Smith also notes that the adoption of single-use manufacturing technology accelerates process validation and analytical testing for Novavax’s vaccines and may allow for ultimate regulatory approval of…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The biosimilars market, many analysts believe, is on the cusp of significant growth. This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expect…
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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…
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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…