Kineret protein solution survives ten years

Area of Science:

• Biopharmaceutical stability
• Protein formulation
• Long-term storage solutions

Background:

• Proteins are inherently unstable in aqueous solutions.
• Typical shelf lives for protein biopharmaceuticals range from months to a few years.
• Extended shelf life is crucial for biopharmaceutical accessibility and national security.

Purpose of the Study:

• To investigate the long-term stability of a protein biopharmaceutical.
• To determine if human interleukin-1 receptor antagonist (IL-1Ra) solution can maintain quality over a decade.
• To assess the potential for meeting national security requirements for extended biopharmaceutical storage.

Main Methods:

• Aqueous solution of human interleukin-1 receptor antagonist (IL-1Ra) was prepared.
• The solution was stored for a period of ten years.
• Quality assessment of the IL-1Ra solution was performed after the ten-year storage period.

Main Results:

• Human interleukin-1 receptor antagonist (IL-1Ra) solution demonstrated remarkable stability.
• The biopharmaceutical solution maintained its quality after ten years of storage.
• This finding challenges the conventional understanding of protein biopharmaceutical shelf life.

Conclusions:

• Protein biopharmaceutical aqueous solutions can potentially be stored for a decade without quality degradation.
• The stability of IL-1Ra offers a viable model for achieving 10-year shelf lives for biopharmaceuticals.
• This breakthrough has significant implications for national security and global health preparedness.