This disruptive technology focuses on the patient, not necessarily current regulatory expectations,” said President, Gary Hutchinson. “The result establishes a direct relationship between transport process and product quality attributes.
Houston, TX (PRWEB) September 24, 2012
Modality Solutions is pleased to announce its unique multi-modal Advantage Transport Simulation Laboratory™. The laboratory provides valuable data on the impact of environmental hazards to critical-to-quality attributes of drug formulations. Modality Solutions’ $1M investment in highly sophisticated technology and engineering provides clients with information on the impact of temperature, humidity, shock, vibration and pressure changes on their products.
Modality Solutions’ subject-matter experts provide insight into cold chain thermal package engineering, transport validation and controlled-environment logistics solutions. Modality Solutions has calibrated and validated to current Good Manufacturing Practices (cGMP) standards the only independent, third-party, multi-modal transport simulation laboratory in the world.
The Bloomington, Indiana-based facility offers testing that adhere to validation best-practices with ISTA and ASTM standards, or can be combined with any client-provided testing protocols. This methodology provides novel data currently unavailable to early stage innovators, researched-based developers, and formulation scientists.
The term “disruptive technologies” was introduced by Clayton M. Christensen in Disruptive Technologies: Catching the Wave. The theory is technologically straightforward – “off-the-shelf” components put together in an architecture that is simpler than prior approaches. Modality Solutions’ simulation innovations can be considered disruptive technology for the biopharmaceutical and medical device industries.
- Current Practice: Stability studies conducted in static iso-thermal chambers to support storage and expiry.
- Innovation: Focus on the product stability from the patient’s perspective – at the end of the supply chain. Expose product to the same conditions it will undergo prior to patient use.
- Current Practice: Designs of Experiments (DoEs) are restricted to the understanding of manufacturing operations only.
- Innovation: Foster a Quality by Design (QbD) approach by tying distribution hazards to the integrity of the product early in the formulation lifecycle when Transport DoEs can help determine the optimum formulation.
These innovations are available with Modality Solutions’ new multi-modal Advantage Transport Simulation Laboratory. In a controlled setting the impact of environmental variables of temperature, vibration, pressure, shock and humidity can be simultaneously studied on the product or the combination of product and selected protective packaging. Transport simulation laboratory testing may be contracted for at hourly or daily rates, on per engagement or assignment basis.
“This disruptive technology focuses on the patient, not necessarily current regulatory expectations,” said Modality Solutions President, Gary Hutchinson. “The result establishes a direct relationship between the transport process and product quality attributes. Product knowledge gained by this approach provides the health care provider with increased confidence in product performance at the point of use.”
For more information, contact Modality Solutions at (888) 219-6317 or visit http://www.modality-solutions.com.
About Modality Solutions, LLC
Modality Solutions delivers integrated cold chain management solutions for highly regulated industries: such as biopharmaceutical, health, nutrition and wellness. The privately-held company provides solutions that define, minimize or possibly eliminate transportation environmental hazards in the supply chain. Consultants provide engineering / logistics consulting, systems integration and simulation laboratory services from discovery through distribution. For more information, go to http://www.modality-solutions.com.