Search results for " scale-up"
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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…
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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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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…
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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…
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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…
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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 …
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Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
This article highlights 15 years of changes in biopharmaceutical manufacturing.
By Ronald A. Rader, Eric La…
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Biopharma Says It Has an Evolution in New Technologies and Processes
A recurring theme was the need for new technologies to accelerate bioprocessing operations and to smooth scale-up from development to GMP processing.
Exhibitors announced new chromatography system…
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Modern Manufacturing Key to More Effective Vaccines
Vaccine development may be even more challenging, she observed, due to limited platform technologies for these products, potential for process change during technology transfer, scale-up difficulties,…