Search results for " scalability"
Article
Single-Use for Downstream Chromatography: Benefit or Hindrance?
Hindrance or help?
Many disposable chromatography columns meet cGMP and industry standards, and also offer reproducibility, scalability, speed, ease-of-use, and operational safety.
However, chr…
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Science Focus Fuels Successful Process Development for Startups
Getting the science right helps biopharma startups overcome development and commercialization challenges.
By Cynthia A. Challener
sdecoret/Stock.Adobe.com
Pr…
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Case Study: Process for Production of Oncolytic Adenovirus
The promising results from clinical studies on the use of viral vectors to address important medical needs have spurred interest in developing scalable and cost-efficient manufacturing processes. Here…
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Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
The biopharmaceutical industry continues to expand in new and exciting ways. What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back …
Article
Scaling Up Novel Therapies
Scaling Up Novel Therapies
Platform processes have improved monoclonal antibody scale-up. Can they do the same for personalized therapies?
By Agnes S…
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A Plastic Pipeline for Commercial Bioprocessing?
A Plastic Pipeline for Commercial Bioprocessing?
The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.
By Rita C. Peters
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Article
Making the Move to Continuous Chromatography
“In this instance, there is a great benefit of starting from the process development step to document scalability,” he notes.
The discussion topic for Sulzberger focuses on whether there is su…
Article
Understanding Validation and Technical Transfer, Part I
The molecule originally identified as possibly having clinical significance must be fully characterized and its synthesis routes developed with the aim of scalability. Formulations to be used in clini…
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Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
The method also has the potential for scalability. Careful analysis of the combined effect of both stimuli on the cells and on the subsequent processing of the product, however, is necessary. Apart fr…
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Going Small to Achieve Success on the Commercial Scale
As a result, it is more difficult to adequately demonstrate the scalability of the models to the level required for qualification,” Jorjorian says. He adds that there is a lot of effort being devoted …