Regulatory Filing Support

Transport Simulation

Transport Simulation Laboratory

Our unique Transport Simulation Laboratory enables the study of concurrent transportation stresses on your biologics and other therapies during the development process including functional testing for plunger movement with your prefilled syringes.

Your drug product is exposed to temperature and humidity, pressure, shock, and vibration hazards. Regulatory expectations are driving the need to incorporate concurrent transport testing into both their development and stability programs.

Five Concurrent Hazards Simulated

  • Temperature
  • Humidity
  • Shock
  • Vibration
  • Pressure

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Examples of Risks by Category

Biologics and Vaccines

Shock and vibration events, in conjunction with temperature have been shown to generate sub-visible particles and inactivate vaccines.

Diagnostics

Reliable results from diagnostics assume the stability of the indicator and are highly susceptible to damage from multiple hazards in the supply chain.

Solid Oral Formulations

While usually thought of as the most physically stable of all pharmaceutical preparations, uncoated tablets can lose pharmaceutical elegance.

Combination Medical Devices

While a combination medical device are convenience, the transport can threaten the integrity of your device and render it defective.

A Few Of Our Regulatory Filing Support Case Studies

A Few Of Our Regulatory Filing Support Case Studies

Questions?
Schedule your free one-hour, no obligation consult.

Schedule A Free Consult

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