Search results for " process" in Articles / App Notes
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
The cell-culture process and media are known to have a significant effect on the expression and stability of therapeutic products as well as their critical quality attributes (CQAs) including glycosyl…
Article
Ensuring the Biological Integrity of Raw Materials
“Essentially, it’s about knowing your manufacturing process, knowing your raw materials, and going deep. Understand exactly what the risks are, then try and mitigate the risk,” Lovatt says. That would…
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A Q&A With Günter Jagschies: Recovery of Biological Products Conference Series
…ant to scientists, engineers, and managers in the bioprocessing field who have a focus on downstream processing. Participants from academia and industry meet and discuss the latest developments in an…
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Cleaning of Dedicated Equipment: Why Validation is Needed
International Conference on Harmonization (ICH) guidance ICH Q9 (1) encourages that a quality risk management approach be considered and that, based on the level of risk, cleaning processes may be sub…
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Vaccine Development and Production Challenges Manufacturers
Researchers are looking for formulations that reduce cold-chain requirements, methods to boost process yield, and new approaches to document product quality.
Some global health advocates, however, …
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Pharma Investments Reflect Key Industry Trends
First is the shift to biologic-based drugs, which has occurred along with a dramatic increase in the productivity, mainly in terms of much higher titers, of biopharmaceutical processes. “While demand …
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Outsourcing Trends in Biopharmaceutical Manufacturing
Beyond typically outsourced activities like fill-finish, validation services, and assays, companies are increasingly relying on their suppliers to address more challenging processes. From expertly pac…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
The industry needs to be prepared to also serve these markets with new business models and novel manufacturing processes. Most likely beyond the more classical Cohn derived processes. Julie Kim also p…
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Benefits of DoE vs mechanistic modeling
You will learn that, quite often, these methods work hand in hand in a hybrid setup to improve your process development!
Watch this webinar on-demand
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Determining and Optimizing Dynamic Binding Capacity
While the same general method is used to determine the DBC for many different biomolecules, matrices, and chromatography operations, all of these variables can influence which process parameters are i…