Search results for "process development"

Article Platform Approach Speeds Process Development
At Boehringer Ingelheim (BI), advances have enabled higher performance benchmarks in time and resources for process development with stringent product quality requirements. An expression platform has …

Article The Development and Application of a Monoclonal Antibody Purification Platform
In addition, these studies would not have been possible without the support of the process development analytics group. JUDY GLYNN is senior principal scientist, TIMOTHY HAGERTY is scientist, TIMO…

Article Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals. The manufacture of biopharmaceuticals presents …

Article Lessons Learned Accelerate Vaccine Development
“Having a deep understanding of the platform was crucial to accelerating the process development effort, because we were able to consider potential issues at larger scale from the beginning,” Redlich …

Article Tools for Continuous Bioprocessing Development
Bioprocess development requires interaction between manufacturer and creator because biopharmaceutical product characteristics and quality are affected by the manufacturing process. Reliable and st…

Article Current and Future Trends in Biosimilar Development: A Conversation with GE's Gunter Jagschies
Process Development: Do you see that the introduction of the biosimilars class has changed the industry in any way? Yes, in several ways. First, innovation is being fostered and the competition ha…

Article Tackling Analytical Method Development for ADCs
process, according to Davidson, and only a few methods may be required to support early conjugation process development, for example, SEC for aggregation, HIC for DAR, and RPC for free drug. Once the…

Article Development of Purification for Challenging Fc-Fusion Proteins
Using a combination of high-throughput process development (HTPD) in a 96-well batch binding format and small-scale column optimization experiments in a flow-through mode, the authors have developed a…

Article Mixed-Mode Chromatography in Downstream Process Development
Several approaches for intermediate purifications were tested during process development. Reversed-phase chromatography under strongly acidic conditions worked well for purification of research-grade …

Article Techniques for Improving Process Development for Exosome-Derived Therapeutics
Here, the Process Development Forum speaks with Aaron Noyes, Head of Downstream Processing, at Codiak BioSciences about exosomes, their potential clinical applications, and process innovations that wo…

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