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 Mapping a Route for Cell and Gene Therapy Process Development
These factors make process development and validation for cell and gene therapies a challenging and highly critical task. Scaling differences Depending on the application (i.e., autologous vs.…

Article Single-Use Technologies Prove Effective for Viral Vector Process Development
Evolution of process development support As single-use technologies have increasingly been adopted for commercial-scale viral-vector production, single-use bioreactor vendors have experienced gr…

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 Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
This opens a wide range of model applications—from early-stage process development via process characterization to process monitoring and control. GoSilico has developed the ChromX™ software. What…

Article Tools for Continuous Bioprocessing Development
As a result, biopharmaceutical process development and scale up are rarely linear. Fundamental understanding of the cellular and biochemical processes involved is often sacrificed because it isn’t alw…

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…

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