Shocking Data on Parcel Shipments of Protein Solutions

Area of Science:

• Pharmaceutical Sciences
• Biopharmaceutical Stability
• Logistics and Supply Chain

Background:

• Biopharmaceutical liquid formulations require rigorous stability testing.
• Shipping conditions can expose drugs to mechanical stress, impacting stability.
• Understanding the effects of shock and vibration is critical for maintaining drug integrity.

Purpose of the Study:

• To assess the physical stability of liquid formulations during simulated shipping.
• To determine the impact of shock and vibration on particle formation in monoclonal antibody (mAb) formulations.
• To evaluate the protective effect of polysorbate against shipping-induced instability.

Main Methods:

• Parcel shipments were conducted between Seattle, WA, and Indianapolis, IN.
• Data loggers recorded GPS, shock (8-36G), and temperature during transport.
• Formulations with and without polysorbate were analyzed for submicron and visible particles post-shipment.
• Controlled drop tests simulated specific shock events (approx. 25G).

Main Results:

• Formulations lacking polysorbate exhibited significant increases in submicron and visible particles.
• Formulations containing polysorbate showed minimal particle changes after shipping.
• Repeated drop tests (25G) induced visible particles but not significant subvisible particle increases, suggesting vibration is also a factor.
• Shock events were found to be repeatable and linked to sorting facility operations.

Conclusions:

• Polysorbate is essential for maintaining the physical stability of liquid mAb formulations during shipping.
• Shipping-induced shock and vibration pose risks to biopharmaceutical product quality.
• Further research is needed to fully elucidate the interplay between mechanical stresses and mAb physical stability.