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 Top Process Development Trends for 2021 and a Look into 2022
But many challenges are associated with the process development for the downstream purification of these molecules. Peter Guterstam, Ph.D., product manager of next generation resins & technologies …

Article Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
… to the BioPharm International expert interview on analytical considerations for successful upstream process development. This interview, conducted independently by the editors of BioPharm Internatio…

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…

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