Search results for " characterization"
Article
Webinar On Demand: Expanding SPR Uses in Antibody Effector Function Determination
Critical quality attributes (CQAs) are fundamental to regulatory compliance. CQAs typically include data on how the candidate interacts with target proteins, as well as process-related CQAs such as pr…
Article
Analytical SEC: How Does Back Pressure Relate to Resolution?
High resolution in HPLC is not achieved by applying back pressure to the column. Let’s straighten out what really helps you achieve high-resolution analytical SEC data.
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Article
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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Protein Analysis with Size Exclusion Chromatography
Size exclusion chromatography (SEC) is widely used in several different analytical applications from basic research to quality control of biotherapeutics. This white paper presents fundamentals abou…
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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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Article
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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A Look at the Affinity Chromatography Landscape
A Look at the Affinity Chromatography Landscape
New ligands are being developed to meet the separation and purification needs of next-gen biologics.
By Cynthia A. Challener
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Analytical exoglycosidases are transitioning from being largely academic tools to being s…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
More consistent and reliable production processes are critical for advancing innovative treatments.
By Jill Wechsler
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Article
A Look into the Future of Biopharmaceutical Quality
A Look into the Future of Biopharmaceutical Quality
Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.
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