Regulatory Stability Considerations for Biological Products

Stability studies are conducted to establish the shelf life and to support shipping and handling conditions for biological drug products.

The regulatory requirement for stability studies to support commercial drug product shelf life is clearly defined by regulatory guidelines. However, these guidelines do not specifically address requirements for clinical drug products. In the absence of sufficient regulatory and technical expertise, it can be challenging to design stability studies that will support a successful regulatory submission to FDA, EMA and other regulatory agencies around the world.

In this publication, you will get insight into regulatory considerations and designs of stability studies, including in-use (compatibility) studies, supporting clinical trial initiation and supporting establishment of shelf lifes.

  • Regulatory requirements for stability information accompanying clinical trial applications
  • Considerations for determining expiry dates for biological products
  • Requirements for study design and analytical methods needed for in-use stability (compatibility) studies of investigational drug products

Key Takeaways

  • No specific regulatory requirements are published by the FDA or the EMA regarding the volume of stability data to include in a clinical trial application, making setting a proposed shelf life challenging.
  • Regulatory bodies expect that stability studies are conducted using representative material and stored in container closure systems representative of those to be used in the trial.
  • Stability-indicating properties of the analytical methodologies must be documented through analysis of stressed samples, and methodologies must be validated in a phase-appropriate manner prior to use in the stability program.
  • Extrapolation of the available stability data is not considered a suitable approach for establishing shelf life for biological products.
  • Reserve samples should be included in the total number of samples placed in the stability chamber - it is recommended that 2X the amount of material required for testing be withheld.

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