Search results for " stability"
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
…ty with the assay, making it useful for establishing comparability, estimating potency and examining stability (17–20). SPR has also shown greater precision and reproducibility than the traditional c…
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Advances in Engineering of Protein-Based APIs
For example, Amgen has developed a stable effector functionless IgG platform to eliminate off-target effects while maintaining the stability and half-life expected of a traditional antibody.
Engin…
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Process Economy Simulations on a Protein A Capture Step
MabSelect PrismA is a next‐generation protein A chromatography resin that offers significantly enhanced alkaline stability and capacity compared with its predecessor products. This application note …
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Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
By Adeline Siew, PhD
CA-SSIS/shutterstock.comIm…
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Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…
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Evaluating Surface Cleanliness Using a Risk-Based Approach
Further consideration should be given to formulation, toxicity, analytical method for residuals, rinsability of components, stability of closed and open containers, and assurance that the product will…
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Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
In the last decade, significant development has also been made in the area of Protein A, both in term of binding capacity and stability, as discussed in a previous Q&A session. What do you feel are th…
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N-Glycan Analysis of Biotherapeutic Proteins
Glycosylation affects a variety of protein biological functions including folding, stability, and activity. These varied functions are enabled by the structural diversity of glycans, which stem from m…
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Improving Process-Scale Chromatography
… and robustness in mAb manufacturing processes by increasing the dynamic binding capacity and alkali stability of Protein A resins.
For other chromatography steps, the introduction of mixed-mode …
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Implications of Cell Culture Conditions on Protein Glycosylation
Glycosylation can potentially affect a protein’s half-life, immunogenicity, binding activity, and stability. It is a complex process that consists of the attachment of carbohydrate moieties, with poss…