Search results for " platform"
Article
Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
At the same time, the production platform selected to manufacture clinical material must be scalable in order to enable the target capacity to be reached and promote cost-effectiveness. Adherent cell …
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Updating Viral Clearance for New Biologic Modalities
…gher levels of viral clearance as well, he says, pointing to MilliporeSigma’s chromatography resin platform, Eshmuno, as an example of a product that offers improved separation of molecules from impu…
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Improving Upstream Predictability
…on introduce an automatic perfusion system that integrates into the company’s Xcellerex bioreactor platform to facilitate intensification during both N-1 and N stages. The company is also working to …
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Mapping a Route for Cell and Gene Therapy Process Development
For cell-therapy applications, Baghbaderani points to the Cocoon Platform from Lonza, an automated GMP-in-a-box concept for patient-scale cell therapy manufacturing, other iPSC platform technologies t…
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Moving PAT from Concept to Reality
This barrier is readily evident with the lack of integration into the existing process equipment installed base, automation platforms, and control strategies, adds Makowiecki. He also comments that th…
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Leveraging Computational Models of Glycosylation for Biopharma QA
…er ovary (CHO) and murine myeloma (NS0 and Sp2/0) cell lines being the most-commonly used production platforms (5). During cell culture, even subtle variations in nutrient availability, dissolved oxy…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
The comparability exercise involves characterization and analysis by a platform consisting of numerous, orthogonal analytical tools (Figure 1). Failing to demonstrate similarity can come at a signific…
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A Look at the Affinity Chromatography Landscape
“As the complexity of the medicines in pipelines increases, so do the processes required to purify them, and these affinity resins allow platform-like approaches to novel molecular entities, reducing …
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Achieving Process Balance with Perfusion Bioreactors
Adams notes that the company’s single-use bioreactors for perfusion also incorporate the same sensor and software platforms provided with its stainless-steel bioreactors, allowing for the same process…
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The Challenge of Disruptive Technologies in Bioprocessing
Disruptive innovations
“Keeping in mind the trends mentioned, there is a focus to improve productivity and have platformable processes for these new modalities, while meeting the high quality and …