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Pharma Stability: Insights, Guidelines, and Expertise

Tag: biologic formulation development

Stability Challenges in High-Concentration Biologic Formulations

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Stability Challenges in High-Concentration Biologic Formulations Managing Stability Concerns in High-Concentration Biologic Formulations As the demand for self-administered biologics increases, pharmaceutical companies are developing high-concentration formulations (HCFs) to enable subcutaneous delivery of large therapeutic doses in small injection volumes. While these formulations offer patient-centric benefits, they introduce significant challenges related to physical and chemical stability….

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  • Calibrate and Validate RH Sensors and Data Loggers to Maintain Stability Compliance

    Understanding the Tip: Why RH sensors and data loggers require control: Relative humidity (RH) sensors and data loggers are essential for ensuring that stability chambers… Read more

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