Search results for " scale-up" in Articles / App Notes
Article
Mapping a Route for Cell and Gene Therapy Process Development
While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.
By Cynthia A. Challener
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Article
Cytiva to Expand KUBio Through Close Collaboration with Pharmadule Morimatsu
Cytiva has announced it will be working closely with Pharmadule Morimatsu to expand its KUBio “factory in a box” so that biopharma manufacturers will be able to quickly scale up vaccines, viral vect…
Article
Best Practices for Selecting a Top-Quality Cell Line
Similarly, production cell lines must be well characterized so that scale-up from shake flasks to large bioreactors does not require extensive optimization.
“Equally important,” stresses Fisch,…
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
On the other hand, cell and ex-vivo gene therapy currently have different facility needs for two primary reasons: need for scale-out rather than scale-up in the case of autologous therapies and the hi…
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Addressing the Complex Nature of Downstream Processing with QbD
“The knowledge we gained during that process will definitely help in the later potential scale-up and commercialization of the product; however, having more of a characterized operating space is not t…
Article
The Value of Digital in Biopharma
Digital technology and data science can be leveraged to add flexibility and ease commercial scale-up.
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Article
Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
…ess Development Forum articles published in 2018:
• Chromatography Scale-Up: Don't Get Tied Down by Bed Height
• Combine Chromatography Techniques: Get the Right Purity/Yield of Prot…
Article
A Look at the Affinity Chromatography Landscape
“Following the successful development of resins enabling the scale-up of AAV production for commercial supply, Thermo Fisher has now set its sights on developing similar products for purification of a…
Article
Achieving Process Balance with Perfusion Bioreactors
While the implications of media consumption from an economic perspective can be determined at small-scale rather effectively, it is in the scale-up phase where the system design is imperative for real…
Article
State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
Since 2003, BioPlan Associates, Inc. of Rockville, MD, has surveyed developers of biotherapeutics and contract manufacturing organizations working in this space about current and projected capacity …