Cell And Gene Articles, App Notes, Case Studies, & White Papers
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Computational Fluid Dynamics For Evaluating Cubical Mixer Performance
3/21/2023
To evaluate mixing performances across new equipment and consumables to ensure consistency, CFD is invaluable in determining the performance of single-use mixers during process development.
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Maximize Product Recovery In Bulk Filtration And Filling Flow Paths
12/15/2022
Explore a fill system designed to automate product draining and recovery within a batch to standardize processes and minimize non-recoverable hold-up within the filtration and distribution flow path sections.
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FDA Recommendations For Gene Therapy For Primary Mitochondrial Diseases
3/18/2024
Explore insight into the strategies and FDA recommendations for executing gene therapy development programs, specifically for primary mitochondrial diseases (PMDs).
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Response To FDA Black Box Warning
3/1/2024
The FDA has launched an investigation into the risk of T-cell malignancies following CAR-T cell immunotherapies. Review the key points of this announcement concerning the CGT research community.
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Mammalian Bioreactors: A Characterization Data Report
12/27/2023
Review experiments that characterize the basic operating conditions of mammalian cultures in single-use bioreactors and parameters to be used when transferring cultures to/from other bioreactor systems.
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The Use Of Injectable Packaging From Early Development To Commercialization
2/20/2024
While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.
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Successful Wetting For Filter Integrity Testing In Volume-Restricted Systems
8/18/2022
Filters with a qualified retention for bacteria, mycoplasma or viruses are commonly used in many pharmaceutical processes. In a validated GMP process, these filters must be routinely tested for integrity.
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Differentiation Of Human PSCs Into mesDA Progenitor Cells
3/31/2023
Discover a cell culture system for the highly specific and efficient differentiation of human PSCs into mesDA progenitor cells in large scale. Learn about the entire process and system performance.
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Get USP Equivalent Data
5/18/2022
Adopting analytical techniques that follow compendial guidelines and meeting their criteria doesn’t have to be difficult, even if you’re using different platforms.
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Strategic Clinical Consulting Success Stories
2/13/2024
Explore real-world examples of how the combination of strategic consulting, regulatory insights, and technical expertise can impact the development and approval process.