Search results for "qbd" in Articles / App Notes
Article
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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Successfully Moving Regulated Data to the Cloud
In light of recent FDA guidance on data integrity, the challenges and benefits of using the public cloud to deploy and use data management software are discussed.
By Stuart Ward
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An Analytical Approach to Biosimilar Drug Development
Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.
By Feliza Mirasol
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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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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …
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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. …
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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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