Search results for " control" in Articles / App Notes
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Top Process Development Trends for 2022 and a Look into 2023
While this certificate-level interactive course on quality by design (QbD) covered fundamental concepts such as the principles of design space and establishing control strategies. Question-and-answer …
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Report from the 12th Plasma Product Biotechnology Forum
With increased knowledge that implemented control strategies, as well as the manufacturing processes, showing no risk of prion contamination, a number of vCJD-related donor deferrals could be removed.…
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e-Learning: what is quality by design (QbD)?
… characterization
- Key aspects of QbD, such as the principle of design space and establishing a control strategy
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Using Modeling to Improve Data Analytics for Upstream Bioprocessing Workflows
Recent trends in data analytics highlight the use of modeling techniques to improve process control and monitoring in biopharmaceutical production.
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Recent Trends in Data Analytics for Upstream Process Workflows
Modeling techniques can improve process control and monitoring in biopharmaceutical production.
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In silico Approaches towards Automated Biomanufacturing
The goal of manufacturing is to control and maintain a commercial process capable of consistently producing a drug of the highest quality and safety. As part of manufacturing science and t…
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Maximum Output Starts with Optimized Upstream Processing
“Waiting for limited capacity to become available is not practical, and the earlier they engage with a potential manufacturing partner, the more control they will have over their timelines and speed t…
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Common Challenges in Cross-Functional Process Development
James is a leading industry consultant with broad chemistry, manufacturing, and controls experience in product development and quality that encompasses early process development to commercial operatio…
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FDA Provides Guidance on Bispecific Antibody Development Programs
This guidance discusses unique aspects for chemistry, manufacturing, and controls (CMC), as well as nonclinical and clinical development programs for bispecific antibodies. Industry and other stakehol…
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Sanitization Opportunities for Protein A Resins
As an alternative, the oxidizing agent peracetic acid (PAA) could be used in the control of such contaminants.
Here, we describe an approach to safely sanitize our new generation bioprocess prote…