Modality Solutions provides insight into cold chain thermal packaging, transport validation, and logistics solutions in highly-regulated and tightly-controlled industries such as life sciences, food, and biotechnology. We integrate your quality systems, risk management, product requirements, validation activities, and your partners seamlessly. Our unique simulation capabilities provide valuable data on the impact of environmental hazards to the critical-to-quality attributes of your product. We enhance our clients’ reputations by ensuring regulatory compliance, product quality, and consumer safety around the globe.
Cold Chain Logistics
Design, Validation, Implementation & Monitoring
In a United Parcel Service (UPS) 2009 survey of large and small healthcare manufacturing companies, UPS found that regulatory challenges were the top supply-chain concern for both large and smaller healthcare companies. The majority of large companies (74%) cite temperature-sensitive concerns as the top regulatory challenge from a supply chain standpoint. Modality Solutions understands and plans from day one for the importance of meeting each client’s unique cold chain challenges. Our team has extensive experience in cold chain design, validation, implementation, and monitoring.
Cold Chain Controlled-Environment Logistics
Environmentally-controlled logistics for supply chains are rapidly evolving. Increasing regulatory scrutiny on global supply chain process controls means more product and process data will be needed to show that the stress introduced during transport does not impact product quality or reduce shelf life.
Our clients’ needs are driven by key global forces:
Based on the convergence of these fast-paced changes, Modality Solutions is ideally positioned to serve as thought leader experts. With our extensive industry knowledge, our team brings a wealth of experience to our clients in the following critical areas:
A Maze of Regulatory Guidances
Let us help you make it from start to finish through the maze of regulations and compliance cold chain management. Both government and industry have established practical guidances for qualifying cold chain temperature-controlled transportation processes, sensors, and packaging in much the same way manufacturing processes are regulated with cGMP. Quality systems are expanding from the manufacturing-centric approach into both the clinical and commercial supply chain. Standalone GDPs, typically a subset of GMP guidance, are new. Over 35 countries have published specific GDP guidances. Although the initial focus in these guidances was on cold chain, regulators have expanded their reach to GS1 serialization standards, anti-counterfeit and diversion concerns, licensed trade partners, quality agreements and data sharing. This increased global focus from regulators has made controlled-environment logistics a standard audit item during any inspection.
Experienced cold chain management experts that support clinical trial operations provide many advantages. At Modality Solutions we offer medical monitoring, product safety, clinical monitoring, and project management. Our goal is to establish a collaborative relationship with our clients to deliver fast, successful, and scientifically sound clinical trial logistics deliverables. With Modality Solutions you get ongoing monitoring, staff training, data query resolution, drug supply accountability, and regulatory document preparation, review and collection. Every member of our team works to maximize clinical trial performance, clinical excellence, data integrity, and patient safety.
We are the experts in cold chain clinical trial logistics, and currently provide operational and technical support to the ongoing CDC-sponsored projects (Ebola vaccination in Sierra Leone), as well as providing assessments of multiple sites for the NIH with its vaccine projects in the Caribbean. We are very knowledgeable of the challenges of delivering refrigerated therapies in Zone 4 geographies. We understand the challenges to both health care staff and the proper storage and handling risks associated with temperature-controlled vaccines.
Design, Development & Qualification
You benefit when you choose a team that includes industry-recognized, subject-matter experts in thermal packaging engineering design, development and qualification. Modality Solutions’ integrated offering of the Advantage Transport Simulation Laboratory testing facility combined with thermal package design engineering is the answer to maintaining product quality and ensuring regulatory compliance.
Thermal Packaging Engineering Solutions
According to Pharmaceutical Commerce, the best estimate of controlled-environment logistics spending in 2008 was approximately $5.2 billion in a $43 billion overall pharmaceutical logistics market. $2.0 billion was spent in specialized distribution packaging and instrumentation, such as insulated boxes, blankets, phase-change materials, active-temperature-control shipping containers and various temperature sensors and recorders. Modality Solutions’ clients leverage over 100 years of combined experience in delivering precise environmental hazards’ protection for biopharmaceuticals, health, nutrition, wellness products and more. Using an iterative process design approach, your product protection is our engineering team’s number one priority.
Ensure Regulatory Compliance, Quality & Safety
Our thermal packaging design and qualification minimize or eliminate transportation environmental hazards in the supply chain. They enhance the reputation of our clients by ensuring regulatory compliance, product quality, and consumer safety during development through clinical trials and into commercial distribution. Modality Solutions’ recognized thought leadership in GMP regulations, standards-based approaches, and compliance solutions differentiates our solutions from more traditional packaging, process development or management firms. Typically these companies focus on single perspectives-- packaging design or testing without bringing the GDP regulatory compliance experience we have to the table. Our principals have demonstrated subject-matter expertise in International Safe Transit Association (ISTA) standards, cGDP regulations, and Parenteral Drug Association (PDA) guidance documents, along with specialized skills in pharmaceutical packaging, import/export, and controlled-environment logistics management.
The Advantage Transport Simulation Laboratory™
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.
Here are a few specific examples of the risks to consider by category:
Biologics and Vaccines
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.
Solid Oral Formulations
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
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.
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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.
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