Search results for "process development"

Article Science Focus Fuels Successful Process Development for Startups
They lack access to revenue streams from existing drug sales to fund their process development efforts, so money must be raised, which requires convincing investors that the ideas they are developing …

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 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 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 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 Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back at some of the most popular Process Development Forum articles from 2018 for cl…

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 …

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