Search results for " cell"
Article
Milestones and Moderate Progress in 2012 Drug Approvals
The enzyme is expressed primarily by muscle cells and adipocytes and is central to the processing of circulating triglyceride-rich lipoproteins.
Glybera is a replication-deficient adeno-asso…
Article
Remote Monitoring and Big Data Advance Upstream Automation
“A single ambr15 experiment generates 48 samples daily, each requiring full analytics with the potential for the resulting data to impact cell culture feed decisions. Automating these activities would…
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Flexible Facilities for Viral Vector Manufacturing
While the initial project looked at a monoclonal antibody (mAb) facility, the team plans to extend the concept to cell and gene therapy production.
Cytiva has amassed expertise in modular design a…
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Tools and Processes for Mature and Emerging Therapies
While technology advances for more traditional biologic-based drugs such as monoclonal antibodies are evolutionary, the processing requirements for emerging cell therapies and gene therapies may requi…
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QbD Improves Cell-Culture Process Control
Mammalian cells are most frequently used as the hosts for manufacturing complex biopharmaceuticals, and cultivation of these host cells is a key factor in the production of biotherapeutics. The cultiv…
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Fusion Proteins Pose Manufacturability Challenges
Challener
Fusion proteins are engineered proteins that contain domains from different proteins that originate from different sources, such as a cell surface receptor or cytokine (i.e., interferon …
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Microbiological Testing: Time is of the Essence
“Occasionally the therapeutic molecule can have toxic effects on the detector cells that are used to detect viruses in in-vitro assays that comply with ICH Q5A (1) and related regulatory guidelines,” …
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Continuous Manufacturing: A Changing Processing Paradigm
In addition, writes Langer, “lag phases are eliminated because cell culture is always at or near peak efficiency” (1). Elimination of process collection and hold steps is a major benefit of continuous…
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Elucidating Biosimilars Characterization
Biological molecules are also manufactured by processes involving living organisms, such as genetically engineered bacteria, yeast, or mammalian cells, and although these processes can be well-defined…
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Report from the 6th International HTPD Conference
Since then, HTPD in chromatography applications has been well established among most biopharmaceutical companies but has also expanded to upstream and cell culture screening as well as to formulation …