Biosimilar App Notes & Case Studies
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Implementing High Cell Density Cryopreservation In Your Seed Train
1/22/2023
Simplify seed train intensification with high cell density cryopreservation. Eliminate the need for manual scale-up steps and enable risk reduction through closed banking and inoculation processes.
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Adapting Single-Use Chromatography To Manufacturing Scale
5/16/2024
Explore strategies for accommodating the ever-increasing upstream titers and volumes to prevent downstream purification from becoming a bottleneck.
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Developing A HIC Polishing Step For The Removal Of mAb Aggregates
9/28/2023
Learn in-depth about the development of a flow-through polishing step that employs hydrophobic interaction chromatography for the elimination of monoclonal antibody aggregates.
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Trends In Next-Generation Delivery Technologies
11/22/2023
Learn how lipid nanoparticles are enabling a new generation of engineered cell therapies with a push toward more complex cell engineering and gene editing for allogeneic therapies.
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Determining The Power Numbers For A Single-Use Mixing System
6/19/2024
In designing a mixing process for scale-up, the power number is a critical parameter. Explore the determined power numbers for a single-use mixer at various mixing speeds and fill levels.
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Integrated Services For Cell Line Preparation And Storage
10/8/2024
Explore a comprehensive suite of services for the manufacture, characterization, and storage of cell banks as well as the advantages of working with an experienced partner.
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Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage
3/24/2023
Learn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.
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Exosome Isolation By TFF And Size Exclusion Chromatography
3/6/2024
Here, we demonstrate a scalable workflow for the isolation of exosomes that combines tangential flow filtration for the concentration of exosomes followed by gentle size exclusion chromatography.
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Bulk Filling Of Drug Substance | Accurate Aliquoting
4/24/2024
Bulk filling drug substances in traditional facilities is often a lengthy, manual process where operators are relied upon to adjust pump controls to achieve accurate filling. This method, spanning multiple shifts, increases process risk through errors that can compromise accuracy.
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Review Of Applications And Processes In Fixed-Bed Bioreactors
5/6/2024
Gain insights and guidelines for developing new processes in this review evaluating publications on the applications of single-use, scalable fixed-bed bioreactors for adherent cell culture processes.