Search results for "regulatory" in Articles / App Notes
Article
Increase Efficiency in Experimentation with Design of Experiments
Design of experiment will not only save you valuable time during screening and optimization, but it will also provide a more rigid and robust process with better end results.
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Article
Automating the Biomanufacturing Process
As automation in biomanufacturing becomes more important, so does the need to integrate process data.
By Feliza Mirasol
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Biomanufacturing proc…
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Experience Compact Scalability
Cost and speed are critical components in biomanufacturing. Can you get a good balance between these two things for your purification tasks, whether you are developing a process or manufacturing at pi…
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Security of Supply
Getting high-quality biotherapeutics to patients on time requires a concerted effort. Working together, suppliers and manufacturers can better understand raw materials and variations that put processe…
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The Good and Bad of Biosimilars
Biosimilars have been around for years, but the biopharma industry – as well as the healthcare community – has been slow to embrace them. Today, however, the competition is really beginning to heat …
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Why, Why, Why…ELISA? A Look at the Benchmark HCP Assay
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Biologics developers and manufacturers demand an accurate and reliable assay for host cell protein (HCP) quantitation. Let’s take a close look at why analytica…
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Sensitive and Reproducible SPR-Based Concentration and Ligand-Binding Analyses
Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and on-going quality control. This art…
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Make the Switch from ELISA to Biacore™ SPR-Based Assays Today
General guidance on how to convert an existing ELISA assay to a Biacore surface plasmon resonance (SPR) assay and how, by doing so, you can get results in less than half the time compared with ELISA. …
Article
Advances in Engineering of Protein-Based APIs
Advances in Engineering of Protein-Based APIs
New platform technologies, advanced modeling tools, and addressing patient needs are important developments.
By Cynthia A. Challener
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Article
Achieve Scalable Viral Vector Production
In our tutorial series on viral vector production, Cytiva scientists share their insights on virus production and how to tackle viral vector manufacturing challenges. In this episode, a scalable produ…