Search results for " manufacturing" in Articles / App Notes
Article
Trends in Downstream Bioprocessing
DSP remains one of the most crucial and talked-about areas of biopharmaceutical manufacturing. Indeed, a survey conducted in late 2012 among 450 global subject matter experts and senior participants w…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
…ogeneity of MAbs is monitored as part of the ongoing control system that ensures product quality and manufacturing consistency throughout the commercial life of the product.15,16 Capillary electropho…
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
The predicted result not only lowers the risk of the manufacturing commercialization effort, but should also be a significant time savings. For a CMO, occupying space in manufacturing or even on the b…
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Trace metals getting you down? Learn what’s really in your cell culture media
Heavy metal might have a place in your music playlist, but heavy metals should stay out of your cell culture media. Heavy metal impurities in your media can have a drastic effect on cell vi…
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Chromatography for the Diversified Antibody Pipeline
…ducing monoclonal antibodies is that we can apply platform processes which makes the development and manufacturing easy. As we shift to a diverse pipeline this may be difficult to engineer in order t…
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Implementing Inline Conditioning to Advance Process Intensification
This week, Bioprocess Development Forum spoke with Filippo Bertoli, Senior Associate Scientist, Séamus McHugh Operations Manager, Joanne Sheehy Staff Manufacturing Process Specialist, Sean Coomey Prin…
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Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management
3, 2020, Cytiva and 4Tune Engineering, a manufacturing-sciences and technology company, announced that they have entered into an agreement to include 4Tune Engineering’s iRISK platform in Cytiva’s cel…
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Biosimilar Quality Requirements
The document also provides recommendations to sponsors on what scientific and technical information to include for the chemistry, manufacturing, and controls (CMC) section of a marketing application f…
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Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…
Article
Cell-Culture Advances Test Bioreactor Performance Models
…tor performance, both for initial laboratory runs and when scaling to the pilot plant and commercial manufacturing.
“Bioreactor performance has consistently improved in biomanufacturing due to a…