Search results for " elemental impurities"

Article Eliminating Residual Impurities Starts with a Strategic Plan
…val of reagents from processes; ICH Q3C (R6) (6) addresses residual solvents; and ICH Q3D (7) covers elemental impurities. At this time, one area that is not currently regulated in detail by th…

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
In addition to these biologics-specific chapters from USP, FDA published draft guidance on elemental impurities in June 2016 (3) following the issuance in 2014 of the International Council for Harmoni…

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 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 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…

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 Challenging the cleanroom paradigm for biopharmaceutical manufacturing of bulk drug substances
The authors re-examine environmental controls in the context of technical advances in manufacturing.  By Simon Chalk, Scott Probst, Paul Gil, Tim Palberg, Matt Kennedy, Joe Rogalewicz, Jeff Johns…

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 Gene Therapies Push Viral Vector Production
Gene Therapies Push Viral Vector Production Kateryna_Kon/Stock.Adobe.com Viral vectors show promise as a delivery mechanism for gene therapy, but which virus types are commerc…

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