Search results for " quality"
Article
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…
Article
Pandemic Alters Policies and Practices for Drug Development and Regulation
FDA continued to promote industry adoption of modern manufacturing methods and advanced quality assurance programs to expand biopharma operations in the United States and overseas.
Broader i…
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A Stepwise Approach to a Digital Transformation in Biopharma
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An interview on “smart” manufacturing—a paradigm shift towards digital transformation for improved safety and quality, optimized performance, and increased complianc…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
Challenges for process monitoring
The ability to monitor and control the bioreactor environment has been shown to enable more reproducible processes and improve viral vector product titer and qu…
Resource
Increase Efficiency with the Right Buffer Management Strategy
There are new buffer preparation methods that can bring significant efficiency improvements over manual preparation while ensuring high quality. This webinar focuses on the sweet spots, advantages, …
Article
WEBINAR ON DEMAND: Increase Efficiency with the Right Buffer Management Strategy
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There are new buffer preparation methods that can bring significant efficiency improvements over manual preparation while ensuring high quality. This webinar focuses on the swee…
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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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High-Quality Chromatography System Meets Predesigned DeltaV for Integrated Manufacturing
Implementing a distributed control system for facility-wide control of biomanufacturing can help overcome these issues by supporting the industry with improved data management and quality control.
Article
EMA Guidance on Changes to COVID-19 Vaccines to Fight Variants
The paper will address options for introducing a new strain into an existing approved vaccine; the minimal regulatory requirements for quality, safety, and efficacy; and bridging studies required to p…
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Updating Viral Clearance for New Biologic Modalities
ICH, Q5A Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin (1999).