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Pharmaceutical Technology

Pharmaceutical Technology-05-15-2020
Volume2020 eBook
Issue 2
Pages: 10–14, 43

Complications in Process Simulation Execution

Author(s):

James P. Agalloco

Regulators have exaggerated expectations for simulated media fills.

Regulators have exaggerated expectations for simulated media fills.

This article reviews aspects of media fill execution in which regulatory expectations have created artificial compliance concerns and significant practical difficulties.

 

Read this article in Pharmaceutical Technology's Biologics and Sterile Drug Manufacturing eBook.

Article Details

Pharmaceutical Technology
eBook: Biologics and Sterile Drug Manufacturing
May 2020
Pages: 10–14, 43

Citation

When referring to this article, please cite it as J. Agalloco, "Complications in Process Simulation Execution," Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook (May 2020).

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On Point: Biologics Drive Growth in Pre-Filled Syringes
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Instrumenting Single-Use Processes
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Considerations in Contamination Control
Best systems and equipment for contamination control
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Building Data Quality In Generates Quality Data Out
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Detecting Contamination in Cell Therapies
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Optimizing Viral Vector Manufacturing for Gene Therapy
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Minimizing Contamination During Biopharma R&D
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Complications in Process Simulation Execution

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