Search results for "regulatory"
Article
Understanding and Controlling Raw Material Variation in Cell Culture Media
Manage variability through advanced analytical methods and risk-based assessment.
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Article
Step Up to GMP Manufacturing or Outsource to a CDMO: Considerations and Tips
Whether you are developing a new monoclonal antibody (mAb), cell therapy, gene therapy, or large-molecule biologic drug, the decision to tackle GMP manufacturing in-house or work with a contract devel…
Article
Robust Business Continuity Program Helps to Maintain Operations in the Face of Crisis
As we began 2020, no one could have foreseen that just a few weeks into the year, we would be facing a pandemic threatening unprecedented damage to human health and the world economy. Businesses are…
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…
Article
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…
Article
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…
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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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Resource
Recovery of Biological Products XIX Conference
This international conference—taking place from July 12–17, 2020 in Rome, Italy—provides exposure to the latest developments in bioprocessing with a focus on downstream processing and aspects that aff…