Search results for " impurity profile"
Article
Eliminating Residual Impurities Starts with a Strategic Plan
Eliminating Residual Impurities Starts with a Strategic Plan
Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.
By Cynthia A. Ch…
Article
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…
Article
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…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability.
Sep 2, 2014
By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…
Article
Quality by design for biotechnology products—part 1
The scope of this paper is limited to well-characterized protein products, in which the natural molecular heterogeneity, impurity profile, and potency can be defined with a high degree of confidence. …
Article
Evolution of the Monoclonal Antibody Purification Platform
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline…
Article
Reimagining Affordable Biosimilars
Geigert, “Complex Process-Related Impurity Profiles,” In The Challenge of CMC Regulatory Compliance for Biopharmaceuticals (Springer, Cham, Switzerland, 3rd ed., 2019), pp. 231-260
J. Gokemeije…
Article
What’s in your media? How costly is variability of cell culture media to your manufacturing process?
We noticed that when we compare from different vendors or the same vendors there is inherent variation in the trace impurity profiles. Once we see this variation, we go back to the source which the va…
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.
…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
Abstract
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