Search results for " future" in Articles / App Notes
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Currently, the program only annotates N-glycan UHPLC-FLR-MS data, but future extended versions will permit structural assignment of other glycan moieties. In the coming years, it is anticipated that s…
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State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
Since 2003, BioPlan Associates, Inc. of Rockville, MD, has surveyed developers of biotherapeutics and contract manufacturing organizations working in this space about current and projected capacity …
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The Challenge of Disruptive Technologies in Bioprocessing
…wledge and an ability to predict process performance, is an essential part of the development of the future of automation solutions, Jagschies adds.
Challenges to disruptive technologies
A si…
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Understanding Validation and Technical Transfer, Part 3
Change records must be current, up to date, supplement the original records, and be available to support future changes.
Conclusion
Validation links the process to the product. Even the best …
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Biopharma Says It Has an Evolution in New Technologies and Processes
Yu, deputy director of the Office of Pharmaceutical Quality in FDA’s Center for Drug Evaluation and Research, talked about the future of pharmaceutical quality—and the challenges of achieving quality …
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Making the Move to Continuous Chromatography
“Clinical manufacturers are motivated to cycle as much as possible using fairly short residence times in order to use less resin early on when the future outcome for a given molecule is still unknown,…
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Biopharmaceutical Market in Asia: Q&A with Günter Jagschies, Strategic Customer Relations Leader, Cytiva
Specific topics will be the review of health challenges in Asia and future approaches to address them, creative technology solutions, facility and regulatory aspects, as well as vaccines and plasma de…
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Full Single-Use Downstream Process? Not Any Time Soon.
Here’s why SUTs will not completely replace reuse systems in the near future.
Continue reading in this blog post.
Article
Impurity Testing of Biologic Drug Products
They also must be defendable in covering all possible options for how the method will be used in the future. Other aspects of method validation are more easily derived from the guidance given in ICH Q…
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FDA Framework Spurs Advanced Therapies
…es” and indicates that “cell therapy is now a sector that has emerged today, not evolving in the future” (2). ISCT also expects the recent approvals to spark considerable investment across all stages…