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BI Insight: Mixing, Diluting, or Repackaging Biological Products

Biologic agents are used in high volumes in oncology and auto immune diseases. The FDA acknowledges that at times, patients require different concentrations due to each patient’s genome. Outsourcing facilities are permitted to repackage biologic agents in order to meet personalized dosages and reduce waste. The FDA Biologic Guidance allows 503B facilities to engage in the dilution, mixing and repackaging of biologic agents without a BLA license. Biomed Innova has a clear understanding of what is required for product validation, including stability processes and quality control for product release.

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