Search results for " Downstream; process development" in Articles / App Notes
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
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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…
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The Development and Application of a Monoclonal Antibody Purification Platform
A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.
The following ar…
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What is process development?
What is process development?
Biopharma process development comprises the activities that help you create a series of steps to produce a biomolecule – a monoclonal antibody (mAb), recomb…
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Top Process Development Trends for 2021 and a Look into 2022
The COVID-19 pandemic continues to shape bioprocess development trends, and many lessons have been learned from industry’s response to and preparedness for dealing with a public health crisis. Howev…
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Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins
This study outlines methods for an alternative protein-polishing process for challenging proteins.
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Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
Spivey and Lane
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Analytic considerations for upstream processing – covering Process Analytic Technology (PAT), time-savings versus off-line ana…
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Process Development: 2020 Reflections and 2021 Possibilities
The challenges posed by the COVID-19 pandemic in 2020 brought about many unprecedented lessons and promising developments in the biopharmaceutical industry. Last year in particular reenforced the ne…
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Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
The biopharmaceutical industry continues to expand in new and exciting ways. What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back …
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability.
Sep 2, 2014
By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…