Search results for " drug sample"

Article Practical considerations for demonstrating drug substance uniformity
The authors describe considerations and best practices for meeting drug substance uniformity. By Sushil Abraham, Eric Rydholm, and Phil Wagner ABSTRACT Drug-substance uniformity is an impo…

Article New Era for Generic Drugs
GPhA backs legislation to make it harder for innovator firms to claim that a restricted distribution program required by a REMS prevents it from making available drug samples needed for bioequivalence…

Article 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…

Article Global Expansion Shapes Drug Oversight
Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions. Few FDA officials discuss pharmaceutical regulation these days without …

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 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 An Analytical Approach to Biosimilar Drug Development
Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars. By Feliza Mirasol …

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 Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling. By Elizabeth Rivera…

Article Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…

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