Search results for " cell"
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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…
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Industry Adoption of Single-Use Systems Remains Low
Additionally, in 2016, the company announced a $7-million expansion project in Westborough, MA (5), where a range of single-use products, including cell growth bags, will be manufactured. Other recent…
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Development of Purification for Challenging Fc-Fusion Proteins
As tested on three Fc-fusion proteins, this process demonstrates high process yield, improved clearance of HMWs and LMWs, and efficient reduction of host cell proteins (HCP) and DNA as well as robust …
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Analysis of Glycosylation in Biosimilars
The pattern cannot be predicted from the genetic code, and the exact nature of the glycosylation depends on the cells and the conditions in which they are cultured. This adds an additional layer of co…