Search results for " QbD"
Resource
International Conference on Harmonization
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmace…
Resource
European Medicines Agency
The European Medicines Agency is a decentralized agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical compa…
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Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
Process development was the only area where over half of respondents plan to offshore in the next five years (although with increased emphasis on QbD and related quality issues, one would presume less…
Article
Selected courses from cell culture and downstream process development to scale-up and manufacturing
Develop your skills and those of your teams with training courses designed for researchers, process development scientists, engineers, and manufacturing operators.
Built upon our expertise…
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How to Use Multiwell Plates With Manual Operation
During process development, aspects like robustness, scalability, and GMP production come into play. FDA initiatives such as quality by design (QbD) put demands on better process understan…
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Top Process Development Trends for 2022 and a Look into 2023
FDA approved 37 drugs in 2022, within the normal range for the past decade or so. The European Medicines Agency (EMA) was even more successful—approving a record 55 therapies. More than half of thes…
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Tools and methodologies for smarter downstream process development
Scibetta
Smart process development is a collection of approaches to improve process outcomes and speed up process development.
In this video, John Scibetta, Advanced Chromatogra…
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Mechanistic vs Statistical Models
Mathematical models are recommended by the ICH Q8 guidelines on pharmaceutical development to generate enhanced process understanding and meet Quality-by-Design (QbD) guidelines. Read on the d…
Article
Considerations for Improving Outcome in Biopharmaceutical Process Development
In this article, we take a look at how the process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different stra…