Our Advantage Transport Simulation Laboratory™ enables the study of transport stresses on your biologics and vaccines, diagnostics, solid oral formulations, and combination medical devices during each stage of the development process. One simulated transport generates data that would take 100 actual shipments to achieve. With the distributed nature of modern lifescience products, your product is exposed to not only significant levels of temperature and humidity variations, but also pressure, shock, and vibration. These five environmental hazards challenge the physical stability of the protein in solution, primary packing and product interface, container closure integrity or even the quality implications of a friable uncoated tablet. Regulatory expectations are driving the leading companies to incorporate transport testing into both their development and stability programs. We can help by providing the additional assurance that after your products are delivered across the global supply chain, they will retain all of their quality attributes until expiry.
Shock and vibration events, in conjunction with temperature have been shown to generate sub-visible particles and inactivate vaccines. The damage boundaries of specific product formulations need to be identified early in the formulation development process to assure clinical success and patient safety.
Reliable results from diagnostics are predicated on the assumption of stability of the indicator. Monoclonal antibodies and antigens are highly susceptible to damage from multiple hazards in the supply chain. The ability of these critical elements to survive the rigors of transport is crucial to the success of the diagnostic test.
While usually thought of as the most physically stable of all pharmaceutical preparations, uncoated tablets can lose pharmaceutical elegance, and in the case of sublingual tablets, actually break apart under certain transport conditions causing dosage difficulties and complaints. Strategies to reduce this damage can be quickly evaluated using transport simulation.
Combination medical devices represent a unique set of risk factors. While a convenience to the user, the transport environment with pressure changes combined with shock and vibration can result in unacceptable plunger movement, excessive drug product contact with needle surface, and a host of other scenarios – all are problematic for "first dose” performance. Find out quickly if your combination device is suitable for transport.
This type of risk-testing defines a design space for the product within the capabilities of the supply chain. Distribution operations often cannot support the tight tolerances of the clinical trial materials. The discovery of this mismatch too late can delay product launch. Safeguard patient safety and protect your product quality from the demanding challenges of today’s global distribution network.
Test the effects of transportation on your presentation and packaging today! Call Paul Harber at (214) 919-4629 Ext. 103 or email email@example.com
Our multi-disciplinary team is ready to help you with your cold chain needs or existing program. For more information, contact us today.