Search results for " detection"
Article
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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Article
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…
Article
Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
By Anurag S. Rathore, Rohit Bansal
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Article
Achieving Process Balance with Perfusion Bioreactors
“Multivariate data analysis (MVDA) using software such as our SIMCA online system allows efficient process control and early fault detection by looking for differences from the ‘golden batch’,” Adams …
Article
Using Multiple Techniques in Biosimilar Analysis
Application of multiple techniques at different conditions presents a more complete picture of a dynamic situation.
By Rebecca Strawn
Sergey/stock.adobe.com
Almost all drug product…
Article
Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…
Article
Biopharma Says It Has an Evolution in New Technologies and Processes
Exhibitors announced new chromatography systems for pilot- and small-scale production, new resins, mixing systems, kits for glycan analysis and mycoplasma detection, filters, and sensors.
As bi…
Article
Making the Move to Continuous Chromatography
Making the Move to Continuous Chromatography
Early adopters are benefiting from lower costs and increased productivity.
By Cynthia A. Challener
Tashatuvango/Shu…
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
Reliability Rooms and the Move to Proactive Supply Chain Management
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict tren…
Article
Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins
This study outlines methods for an alternative protein-polishing process for challenging proteins.
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