Search results for " design" in Articles / App Notes
Article
FDA Approves First Biosimilar
Biosimilar, but not interchangeable
While the approval is based on strong evidence, says FDA, the agency is careful to state that the biosimilarity designation does not imply interchangeability. A…
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Technologies and Practices Must Evolve to Meet Demand
Process improvement efforts
In the 2014 survey, 68% of the respondents indicated that their companies had implemented quality by design (QbD). In the 2015 survey, this number grew to 72.5%. More t…
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
This two-part Q&A series with Anurag Rathore, PhD, Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi, reveals the evolution of QbD, the types of companies implementi…
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Bureaucratic Roadblocks Threaten Biopharma Growth
The 2014 BIO International Convention, taking place June 23-26 in San Diego, will host an Emerging Opportunities in Global Markets Forum specifically designed to highlight biotech initiatives in globa…
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Raw Material Variability
Quality-by- design approaches to specifying requirements are key and getting to variability true root causes of variability is crucial.
For the manufacturers cross-functional teams covering o…
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Biopharma Outsourcing Activities Update
On the other end of the spectrum, design of experiments (DoE) (34.1%), downstream process development (36.3%), and quality-by-design (QbD) services (37.4%) are the least likely to be outsourced, altho…
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2014 Manufacturing Trends and Outlook
Quality by Design
Improved process understanding (68.4%), improved product quality (66.7%), and reduced variability in product quality (57.9%) were the top advantages identified by the responden…
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ReadyToProcess WAVE 25 Bioreactor System
The system is designed for fast installation and convenient handling, and delivers a reliable and accurate performance suitable for research, process development, and manufacturing operations.
Lea…
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Evolution of the Monoclonal Antibody Purification Platform
The profiler shown for the model is constructed using design of experiment with varying PEG and citrate weight percentage. It is possible to remove HMW completely by appropriate mixture percentage of …
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Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical manufacturers’ change-control systems are designed to ensure that any changes to raw materials, product contact materials, manufacturing methods, product tests, and production equipment…