Search results for " residual impurity testing"

Article Eliminating Residual Impurities Starts with a Strategic Plan
… in the long term because it enables risk-based residual impurity control and minimizes the need for residual impurity testing. Numerous risk factors Residual impurities in biopharmaceutical p…

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 Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures. By Cynthia A. Challener Manufacture of protein and other biologic drug substances via …

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 Bioterminology: A Guide to the Biopharmaceutical Lexicon
Bioterminology: A Guide to the Biopharmaceutical Lexicon This lexicon was generated by the editors of BioPharm International magazine. Please feel free to email your suggestions for terms that s…

Article An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…

Article Host-Cell Protein Measurement and Control
Jun 01, 2015 By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem BioPharm International Volume 28, Issue 6, pg 32–38 Host-cell proteins (HCPs) constitute a major part of proce…

Article Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech. By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…

Article Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product. Feb 01, 2015 By Anthony Grilli BioPharm…

Article Mixed-Mode Chromatography in Downstream Process Development
Salt-tolerant adsorption and unique selectivity are the major advantages of mixed-mode materials over single-mode resins. By Felix Oehme, PhD, and Joerg Peters, PhD ABSTRACT Mixed-mode chroma…

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