Search results for " process"
Article
e-Learning: what is quality by design (QbD)?
The focus lies on applying QbD to process development of biopharmaceuticals.
Key learnings:
- Fundamentals of the QbD concept
- How QbD fits within process development and process charact…
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Next Generation Bioprocesses: Mapping Roads to the Future
So what are next-generation processes?
These processes overarch the whole manufacturing chain—from cell to molecule and upstream to downstream. They include semi-continuous and continuous approach…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
By Jill Wechsler
While cell- and gene-therapy products hold the promise of transforming the treatment of many diseases, difficulties in achieving consistent process control could sty…
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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…
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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…