Cold chain experts Modality Solutions have published and made available for free its new white paper, ‘Drug Product Formulation Testing with Transport Simulation’.
The full-service engineering firm provides simulated testing for drug product formulations. The goal of the drug formulation simulation study is to concurrently expose drug product to all five environmental hazards (temperature, shock, vibration, humidity, and pressure) as they occur during real-world distribution.
With Modality Solutions, a cold chain regulatory filing authority, logistics network operations, and an integrated expertise staffing firm combine as a single source for cold chain management integration for the life sciences industry.
The company’s white paper outlines a new approach for stability studies. The new study uses an integrated methodology for testing for the 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 (shock, vibration, temperature, humidity, and pressure) 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.”
Visit www.modality-solutions.com to download the Drug Product Formulation Testing with Transport Simulation white paper.