In-Use Physicochemical Stability of Sandoz Rituximab Biosimilar in 0.9% Sodium Chloride Solution After Prolonged...

Area of Science:

• Biopharmaceutical stability studies
• Drug product quality assessment
• Biosimilar characterization

Background:

• Standard stability studies for biologics may not fully encompass patient safety aspects.
• Assessing in-use and out-of-fridge conditions is crucial for biologics like Sandoz rituximab biosimilar (SDZ-RTX).

Purpose of the Study:

• To investigate the physicochemical and biological stability of Sandoz rituximab biosimilar (SDZ-RTX).
• To evaluate the impact of worst-case storage conditions on SDZ-RTX quality.

Main Methods:

• Exposure of SDZ-RTX batches to long-term (36 months), out-of-fridge (up to 30°C for 21 days), and in-use (up to 30°C for 14 days) conditions.
• Dilution to 1 mg/mL in 0.9% NaCl and storage in infusion bags under simulated in-use temperatures.
• Comprehensive stability assessment using size-exclusion chromatography, cation exchange chromatography, capillary electrophoresis, bioactivity assays, and particle counting.

Main Results:

• All assessed parameters for SDZ-RTX remained within stringent shelf-life acceptance criteria.
• Both batches of SDZ-RTX demonstrated stability under both tested in-use conditions.

Conclusions:

• Physicochemical and biological quality of SDZ-RTX is maintained when diluted in 0.9% NaCl infusion bags.
• Stability is assured even after extended worst-case storage at elevated temperatures up to 30°C, provided aseptic preparation.
• These findings support the safe use of SDZ-RTX under challenging storage scenarios.