Search results for " characterization" in Articles / App Notes

Article Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics Kinetic models can be used to study aggregation and fragmentation to help ensure stability. By Anurag S. Rathore, Rohit Bansal …

Article Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3 Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…

Article Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development. The structures of protein drugs such as monoclonal antibodies are mad…

Article Tools for Continuous Bioprocessing Development
Could perfusion microbioreactors bring more agility to biomanufacturing? By Rajeev J. Ram In semiconductor manufacturing, for example, a thorough understanding of process variation allows co…

Article Application of Quality by Design to Viral Safety
A quality-by-design approach defines a range of potential viral contaminants of source materials and can be used to effectively achieve viral clearance. Oct 1, 2014 BioPharm International …

Article Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology. By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…

Article Current Techniques and Challenges Presented in Scaling Between Bioreactors
cell culture   In this video, Andreas Castan, Strategic Technology Partnerships Leader at Cytiva, discusses the current techniques and challenges in scaling between bioreactors.  …

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 Technology Innovations Improve Process Chromatography Performance
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved. By Feliza Mirasol Selecting an appropriate separation technology fo…

Article Eliminating Residual Impurities Starts with a Strategic Plan
Eliminating Residual Impurities Starts with a Strategic Plan Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach. By Cynthia A. Ch…

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