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 Single-Use Technologies Prove Effective for Viral Vector Process Development
The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages. Cynthia A. Challener  Upstream viral-vector processes can have sig…

Article Maximum Output Starts with Optimized Upstream Processing
“The upstream processing industry, especially in the SU space, was already experiencing significant demand and growth pre-COVID-19. With the rapid development of new COVID-19 vaccines and therapeutics…

Article Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals. By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…

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…

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