Methods: Model proteins were tested at low concentration of 0.35 mg/ml to as high as 25 mg/ml. Aggregation was tested via visual inspection of particulate formation and quantification of turbidity changes by optical density measurements at 350 nm before and after storage and/or shipment of samples. Adsorption was tested via quantification by monitoring changes in absorbance at 280 nm before and after storage of samples.

Results: Under low protein concentrations, no unambiguous generalization could be drawn regarding the effect of silicone oil on the extent of aggregation of the model proteins. At protein concentrations as high as 25 mg/ml, however, an effect of silicone oil on protein aggregation was observed, especially under agitation and air shipment of samples.

Conclusion: Silicone-free CZ syringes showed a reduced extent of aggregation compared to siliconized glass syringes under the conditions examined. It is recommended that the effect of silicone oil on the aggregation of therapeutic proteins and their susceptibility to silicone oil induced aggregation be investigated before finalizing stabilized formulations.

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