Search results for " upstream processing"

Article QbD and PAT in Upstream and Downstream Processing
CQAs are typically also release tests, although they don't have to be as there are no real release tests as such in upstream processing. The variability and complexities associated with the upstre…

Article Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 4 Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …

Article Mapping a Route for Cell and Gene Therapy Process Development
While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar. By Cynthia A. Challener …

Article Achieving Process Balance with Perfusion Bioreactors
Advances in single-use technologies, sensors, and cell retention systems facilitate processes designed for the long run. By Cynthia A. Challener  MG/Stock.Adobe.com …

Article Continuous Processing for the Production of Biopharmaceuticals
The industry already has experience in terms of continuous upstream processing. Perfusion technology has been successfully used for the production of biotherapeutics for more than a decade. In the pas…

Article Technology Innovations Improve Process Chromatography Performance
…p What is the downstream response to upstream scale up as the industry sees increasing titers in upstream processing resulting from increased sizes of single-use bioreactors and optimized cell cu…

Article Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes. By Susan Haigney natali_mis/Stock.Adobe.com Regulators have been en…

Article Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development. By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig C…

Article Optimizing Late-Stage and Commercial Cell-Culture Processes
Optimizing Late-Stage and Commercial Cell-Culture Processes Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing. By Feliza Mirasol …

Article Leveraging Data for Better Biopharmaceutical Process Control
Are more biomanufacturers adopting PAT and advanced control in biopharma? Menezes:The initial use of PAT in bioprocessing was focused on monitoring specific culture attributes in upstream proce…

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