Search results for " system"
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Advancing Single-Use Technology Through Collaboration
Single-use systems minimize the risks for cross-contamination between batches, can be set up more quickly than traditional fixed systems, can lower operating costs per batch, and may allow for market …
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Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
Some components of chemical and biological origin contained in sophisticated cell-detachment systems are unstable and have a short shelf-life.
Production costs
Expensive cell-detachment system…
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Regulatory Challenges in the QbD Paradigm
It appears that the new desired state can be achieved or at least approached with the adoption of two main elements by the pharmaceutical industry and by FDA: QbD and effective, agile quality systems …
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Mapping a Route for Cell and Gene Therapy Process Development
Looking at cell therapies, Baghbaderani notes that the main differences in scaling allogeneic applications lies in the cellular characteristics, cell culture systems, and unit operations utilized in t…
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Aseptic Processing: Keeping it Safe
…maximum personnel load should be used, especially for long periods of time, whereby the air handling systems may be overwhelmed.” Singh adds, “Routine monitoring activity is an integral part of the n…
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Trends in Single-use Bioreactors
In addition, there are improved control systems that allow multiple unit operation and sophisticated feed strategies improving cell yield and increasing titer with single-use bioreactors. Ergonomic fe…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Before an analytical method can be incorporated into a characterization platform or a quality control system, it must first demonstrate that the method is suitable for its intended purpose. Guidelines…
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Optimization of Protein Expression in Escherichia Coli
One of the most commonly used protein expression systems uses Escherichia coli as a protein factory. E. coli has many advantages—including rapid growth, ease of scale up, and low costs—but it poses ch…
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Sterilization Trends for Single-Use Consumables
Controlling the sterilization process so that it delivers a sufficient minimum dose over the entire surface of the component to kill microbes and render the SU system sterile is also crucial, Hathcock…
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
The increasing popularity of single-use bioreactor systems and continuous processing techniques have brought both new opportunities and challenges to upstream bioprocessing. Together, these trends hav…