Written by Modality Solutions
Posted on: August 12, 2020
Modality Solutions new white paper details how simulated transport is a valuable technique for determining the physical stability of drug product protein solutions, including vaccines, monoclonal antibodies, antibody-drug conjugates (ADCs), and gene therapies. Large molecule drug products may be susceptible to degradation when exposed to common transport hazards. Simulation testing exposes the product to the concurrent combination of these hazards at worst-case edges of your operating space in the global supply chain. Unlike ASTM-based testing, the hazards are applied with realistic durations and intensities that reflect the supply chain’s risks.
The white paper explains:
- The simulation testing concurrently exposes the product to the five major transport hazards affecting drug product quality: shock, vibration, temperature, pressure, and humidity at the edges of your operating space.
- Analytical results from samples exposed to worst-case transportation hazards demonstrate product robustness during simulated shipping.
- Non-accelerated profiles are selected because they reflect the energy levels and intensities in the supply chain. The goal is not to accelerate the testing, but to replicate all the hazards in transit.
“An understanding of these methodologies is vital to ensure the simulated transport hazards reflect the actual cold chain for each therapy. “If correctly planned and executed to be included in the BLA, analytical results from samples exposed to concurrent transport simulation are considered industry best practice.”
— Modality Solutions President, Gary Hutchinson.
Click here to view the Simulated Transport Methodologies White Paper press release.