Full-service engineering firm Modality Solutions offers drug product formulation testing with transport simulation for drug product formulations to concurrently expose drug products to temperature, shock, vibration, humidity and pressure, as they occur during real-world distribution.
Modality Solutions combines a cold chain regulatory filing authority, logistics network operations and an integrated expertise staffing firm as a single source for cold chain management integration for the life sciences industry.
The drug product formulation testing with transport simulation is a new approach to stability studies that uses an integrated methodology for testing different hazards as they occur in the supply chain.
During the simulation testing, industry standards in the following areas were questioned, tested, and analysed:
- Hot and cold temperature profiles
- Non-accelerated vibration effects
- Exposure to multiple pressure gradients
- Parcel-based drop/shock events
An understanding of the shipping lanes is necessary to ensure the simulated transport reflects the actual cold chain. If correctly planned and executed, analytical results from samples exposed to concurrent transport simulation included in the Biologic License Application (BLA) filing are considered industry best practice.
An initial transport simulation study is advised well before filing. This first test may be on engineering batches or prior to a final formulation decision. This allows for an appraisal of multiple candidate formulations, de-risks the subsequent development path, and builds product knowledge at the earliest possible time in development.
The inclusion of data from samples exposed to the appropriate simulated hazards can replace the need for extensive studies from actual shipments. A sufficient number of samples from the validation batches are used for this test and analysed with the registration stability samples. This allows a comparison to be made between transported and quiescent samples. The results are then shared in the BLA filing.
Modality Solutions’ president Gary Hutchinson said: “Regulatory expectations are driving leading companies to incorporate simulated transport testing into both their development and stability programmes.
“Our Advantage Transport Simulation Laboratory™ enables the study of transport stresses on early-stage drug formulations during the development process and verification of the robustness of the commercial drug product formulation.”