Search results for "qbd" in Articles / App Notes
Article
Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
On February 9, 2012, almost two years after the Biologics Price Competition and Innovation Act was passed, FDA released draft guidelines concerning the regulatory path for biosimilars. Amy Ritter, S…
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PDA's Technical Report for Biotech Cleaning Validation
The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation.
By Anurag S. Rathore, D…
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Preclinical Evaluation of Product Related Impurities and Variants
The data from these studies is together used to make overall risk assessment by assigning a severity score to each variant, in accordance with the principle laid down in quality-by-design (QbD) paradi…
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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…
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Selected courses from cell culture and downstream process development to scale-up and manufacturing
Examples of available free of charge eLearning courses:
What is quality by design (QbD)?
Principles of cell line development
Bioreactor scaling
Filtration in bioprocessin…
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How to Use Multiwell Plates With Manual Operation
FDA initiatives such as quality by design (QbD) put demands on better process understanding. High-throughput tools like PreDictor™ plates prefilled with chromatography resins make it possible to explo…
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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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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…
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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…