Search results for "buffer management"

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 Single-Use for Downstream Chromatography: Benefit or Hindrance?
Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption. By Feliza Mirasol ARTMOIS/STOCK.ADOBE.COM Biopharmaceutical manufactu…

Article The New World of Biopharmaceutical Manufacturing
Industry experts discuss the single-use revolution and changes to upstream and downstream processing equipment. By Jennifer Markarian …

Article Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design. By Peter Genest, John Joseph The benefits of adopting single-use technologies in the production of biopharmaceuticals…

Article Reducing Cross-Contamination Risks in Process Chromatography
Reducing Cross-Contamination Risks in Process Chromatography Single-use systems provide replaceable fluid paths. By Cynthia A. Challener …

Article Selecting a Comprehensive Bioburden Reduction Plan
Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination. By Randi Hernandez There are multiple variables to consider …

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 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 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 Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
   Readers also wanted to dig into other tools for process intensification such as buffer management. One hot article answered two commonly asked questions about in-line buffer preparation, which …

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