Search results for " quality"

Article Achieving the Required Buffer Quality with Inline Conditioning
A study was conducted to compare buffers produced with IC and buffers produced manually to see if their quality was equivalent. Read full article here.

Multimedia Cell Culture Media Considerations and Optimization for Improved Titers and Protein Quality
Peggy Lio, Senior Director of Global Cell Culture Services at Cytiva, explores the evolution of bioprocessing over the last 30 years, parameters to consider when developing cell culture media, and wha…

Article Cell Culture Media Considerations and Optimization for Improved Titers and Protein Quality
… Cell Culture Media and Feeds Read our case study on Improving Cell Culture Titer and Protein Quality

Resource Guidance for Industry: Quality Considerations in Demonstrating Protein Product
FDA's guidance for Industry Quality Considerations in Demonstrating Protein Product

Article Innovative Chromatography Resins Can Improve Purity and Quality
By: Feliza Mirasol Recent innovations in chromatography resins offer promising advantages in downstream bioprocessing. With ongoing efforts to increase monoclonal antibody (mAb) productivi…

Article Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management
The collaboration addresses the need for risk mitigation plans in cell therapies. On Dec. 3, 2020, Cytiva and 4Tune Engineering, a manufacturing-sciences and technology company, announced that th…

Resource Challenge Analytical Complexity: Biacore™ SPR Systems for Candidate Selection, Characterization, and Quality Control
http://www.processdevelopmentforum.com/articles/challenge-analytical-complexitybiacorespr-systems-for-candidate-selection-characterization-and-quality-control/

Article Challenge Analytical Complexity: Biacore™ SPR Systems for Candidate Selection, Characterization, and Quality Control
This webinar presents the utility of Biacore™ systems at all stages of the process, from selection of first candidates to clinical lead, as well as how to shorten and streamline the time to results …

Article Quality by Design in Biotherapeutics Purification: Understanding and Addressing Sources of Process Variability
Click here to download the white paper now >> The principles and methodologies of biopharmaceutical manufacturing are well established today. However, the increased molecular diversity br…

Article Regulatory Challenges in the QbD Paradigm
Implementation of quality by design (QbD) in this environment has further contributed to the need to clarify what information needs to be included in a regulatory filing and how it should be presented…

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