Search results for "regulatory" in Articles / App Notes
Article
The Path to High-Quality Immunoassay Reagents
How Biacore surface plasmon resonance is shaping today’s assay development and selection of diagnostic reagents.
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Article
Introducing Process Characterization Kit: New Tools for Gaining Deeper Chromatography Process Understanding
Study the potential impact of resin ligand density on process outcome with Process Characterization Kits. The kits provide critical insights on resin variation within the ligand density specificatio…
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Studying Resin Variability Using a Process Characterization Kit
Learn how Process Characterization Kits can be used to assess the potential impact of resin ligand density variability on product quality and process performance.
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Five Control Strategy Options to Prevent Resin Variability Impact
Control strategies that assure product quality and process performance are essential in biomanufacturing. Here are the pros and cons of five control strategies that can provide process consist…
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2019’s Top Bioprocessing Trends and What to Expect in 2020
…nd process economic advantages compared with more traditional methods, all the while staying within regulatory guidelines.
Efficiency Improved by New Technologies
Technological advances…
Article
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
Legal experts in biopharmaceutical patent law shed some light on trends and recent news.
By Agnes Shanley
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Article
A New Paradigm in Process Development
Accelerate biologic manufacturing of mAbs, vaccines, and novel biotherapies. Download this e-book for case studies and insights from Janssen, Roivant Sciences, and mAbxience.
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Getting it Right from the Start in the Drug Development Process
Proper process understanding allows researchers to critically identify factors that impact the drug substance and product as well as minimize or maintain them at approved levels. As a result, the de…
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Jefferson Institute for Bioprocessing Opens Near Philadelphia, PA
With the mission of providing state-of-the-art education and training in the fast-emerging field of biopharmaceutical processing, the Jefferson Institute for Bioprocessing (JIB) formally opened its …
Article
Viral Clearance: 7 Chromatography Column Considerations
Viral clearance studies are a critical part of the production of biologics. However, performing studies that are accurate and cost-effective can be challenging.
Here are seven things to conside…