Search results for " viral vector production" in Articles / App Notes
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
The commercialization of cell and gene therapies has become a reality, prompting deeper considerations of logistics, technology, and design for manufacturing facilities.
By Feliza Mirasol
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A Look at the Affinity Chromatography Landscape
A Look at the Affinity Chromatography Landscape
New ligands are being developed to meet the separation and purification needs of next-gen biologics.
By Cynthia A. Challener
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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…
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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 |…
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Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012.
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…
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Emerging Therapies Test Existing Bioanalytical Methods
Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex thera…
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Scalable Viral Vector Manufacturing
This results in a large demand for viral vector production. Furthermore, there is also a shortage in available manufacturing capacity within many companies as well as in contract manufacturers.
Wh…
Article
New Therapies Present Scaling Challenges
New Therapies Present Scaling Challenges
Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an al…
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Lessons Learned Accelerate Vaccine Development
Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing.
By Cynthia A. Challener
Vaccine development is a complicated process that can take many yea…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
Olivier Le Moal/Stock.Adobe.com
By Cynthia A. Challener
Facility and equipment design are important, but the team and its experience matter most.
Through its Operation Warp Speed pro…