Search results for " raw material control"

Article Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle. With the most recent FDA …

Article Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The authors review efforts to limit polymer degradation without significantly impeding cell growth. Jan 01, 2015 By Sara Ullsten, Shujian Yi, Jeffrey Carter, Eva Lindskog, Pokon Ganguli, Her…

Article Leveraging Data for Better Biopharmaceutical Process Control
Leveraging Data for Better Biopharmaceutical Process Control The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and dow…

Article QbD Improves Cell-Culture Process Control
QbD Improves Cell-Culture Process Control A quality-by-design approach that implements PAT offers advantages in upstream cell-culture processing. By Feliza Mirasol Mar…

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 Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Advances in cell culture media technology have helped achieve safer biologics. By Tom Fletcher, Holden Harris Regulatory expectations for cell-culture-based biologics production processes ch…

Article Application of Quality by Design to Viral Safety
A quality-by-design approach defines a range of potential viral contaminants of source materials and can be used to effectively achieve viral clearance. Oct 1, 2014 BioPharm International …

Article Quality by design for biotechnology products—part 2
Second in a three-part series that discusses the complexities of QbD implementation in biotech development. By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman…

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…

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