Search results for " cell" in Articles / App Notes
Article
Scaling Up Novel Therapies
Developers are exploring how these platforms might be used in novel therapies such as cell and gene therapies. Although these treatments are in early stages of development, gene therapy has already be…
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Putting Viral Clearance Capabilities to the Test
Raw materials and cell substrates must be characterized using molecular, in-vitro, and in-vivo testing strategies, she says, and cell banks and end-of-production cells are tested to identify species o…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
By Jill Wechsler
Amid mounting excitement over remarkable efficacy rates for new genetically modified cellular therapies, regulators and manufacturers alike face continuing challeng…
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Moving PAT from Concept to Reality
In addition, a variety of on-line tools measure cell density (dielectric spectroscopy, fluorescence spectroscopy); protein aggregates (size-exclusion chromatography and ultra-high-performance liquid c…
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Optimizing Late-Stage and Commercial Cell-Culture Processes
Over the years, cell-culture processes have evolved to achieve optimum production yield and quality for both clinical development and commercial manufacturing.
Cell-culture evolution
Current c…
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FDA Framework Spurs Advanced Therapies
Markets and Markets estimates the value of the regenerative medicine market (including cell and gene therapies, immunotherapies, and tissue engineering) will grow at a compound annual growth rate of 2…
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Ensuring the Biological Integrity of Raw Materials
Although contamination can occur from the cell culture itself or from labware and the laboratory environment, raw materials are the most significant source of contamination, which can lead to false re…
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A Closer Look at Affinity Ligands
Large-scale manufacturing of a therapeutic monoclonal antibody (mAb) starts with the expression of the antibody in mammalian cells, typically CHO [Chinese hamster ovary] cells, followed by a series of…
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What’s New in Upstream Technologies
Bench-scale automated cell culture system
The scale-X carbo, from Univercells, is a bench-scale automated cell culture system for the expression and concentration of viral drug substance suited fo…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Companies such as Sandoz and Celltrion, which have both received FDA approvals for biosimilars, have had success in using real-time, label-free biophysical analytics as a platform approach for product…