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Modality Solutions|24 February 2016

Transport Simulation Laboratory

Modality Solutions operates our Advantage Transport Simulation Laboratory™ that has been continuously validated to current GMP (Good Manufacturing Practices) since its installation in 2012.

The Advantage Transport Simulation Laboratory™ concurrently studies the impact of temperature, humidity, pressure, shock and vibration.

Modality Solutions operates our Advantage Transport Simulation Laboratory™ that has been continuously validated to current GMP (Good Manufacturing Practices) since its installation in 2012.

Recent biopharmaceutical drug products arriving in the market are therapeutic proteins with unique environmental sensitivities that could alter their efficacy if not mitigated during transportation. We test drug product integrity while exposed to changes in:

Practical and valuable implications of the environmental hazard testing during transportation

As part of the biopharmaceutical industry guidance, all drug products require validation for the transport from the manufacturer to the patient and intermediate steps. In order to prepare any drug formulation for the transport hazards, we developed the simulation technology and associated test profiles that simulate the conditions inside an aircraft, the back of the truck and even in a container on the deck of an ocean carrier.

While we test for the five environmental hazards: temperature, shock, vibration, humidity and atmospheric pressure changes, and evaluate the drug product quality, we also emphasize the last-mile exposure risks during delivery to the patient. These results not only mitigate patient risk by selecting the appropriate shipper and packaging but also allow manufacturers in early developmental phases to alter the formulation to lessen the risks during commercialisation.

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