Search results for " QbD"
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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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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…
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Supply Chain Challenges for Single-Use Systems
Suppliers address the complexity of supplying disposable components to the global biopharmaceutical manufacturing industry.
By Jennifer Markarian
The implementation of sing…
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Ensure SEC Column Reproducibility in Protein Drug Analysis
Size exclusion chromatography (SEC) is the go-to analytical method in the analysis of therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you…