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Cold Chain Engineering
Modality Solutions’ experts help optimize your cold chain during clinical trials and after commercialization.Request a Consultation
Once your therapy achieves regulatory approval and reaches the commercial market, your cold chain still needs attention. Unless you optimize your cold chain for the rigors of the commercial network, you’re exposing yourself and your patients to safety risks and unnecessary costs.
Our Cold Chain EngineeringTM experts provide Cold Chain Optimization Solutions that enhance the performance of your supply chain for temperature-controlled therapies—managing your assets, ensuring patient safety and drug efficacy, and keeping your costs manageable.
For companies with therapies in the post-commercial phase, Modality Solutions is the ideal Cold Chain EngineeringTM partner to optimize your cold chain. Large pharmaceutical manufacturers, emerging biopharmaceutical companies, and the makers of drug-device combination products rely on our cold chain expertise and engineering know-how to optimize their supply chains for therapies that have already reached the commercial market.
Our Cold Chain Optimization Solutions can drive down shipping and packaging costs, verify the suitability of new shipper types, investigate and solve cold chain issues occurring in the field, determine the optimal shipping routes, and train your team on industry-recognized best practices for pack-out and other critical procedures.
BMS Case Study:
With therapeutics requiring controlled temperatures ranging from refrigerated to deep-frozen to cryogenic, Bristol-Myers Squibb (BMS) needed to qualify a variety of shipping container options. Modality Solutions was brought in to confirm how long a proof-of-concept…View the case study now
Modality Solutions’ cold chain experts have much more than their deep packaging engineering experience at their disposal. They also leverage the most advanced AI and machine learning technologies on our cold chain optimization engagements. Our AI-driven packaging optimization application combines predictive weather data and real-time shipping lane information to analyze hundreds of problems per minute—generating a decision-support matrix that helps you choose the optimal packaging type and avoid unnecessary costs.
Our Cold Chain Optimization Solutions focus on three key factors that can significantly impact your ability to protect a therapeutic from environmental hazards in transit: optimized package design, package selection, and logistics network design.
Even a commercially approved therapy may not be making use of the best packaging for protection against temperature excursions and other hazards. Our cold chain engineering experts regularly work with pharmaceutical manufacturers and biopharma companies to evaluate and qualify their thermal packaging, ensuring they’re taking the best approach.
Leveraging lane-specific weather data updated every 4 hours and AI-driven packaging modeling, our team can develop specifications for critical-to-quality packaging components, evaluate current and new packaging options, verifying packaging suitability for a particular therapy, model packaging performance under worst-case conditions, identify factors impacting risks like heat transfer, compare test results to real-world validation data, and help select the most cost-effective packaging by lane and by day for each therapeutic.
Choosing the optimal thermal packaging, backed by the right service level, is the only way to protect your drug product without over-engineering the packaging solution.
Only Modality Solutions can combine deep Cold Chain EngineeringTM expertise with an AI-driven software tool that helps you choose both the right packaging and the least-cost routing. We use AI and machine learning technologies, combined with predictive weather data and real-time shipping lane data, to model the conditions your therapeutic will face during transportation. We arrive at a variety of packaging options, each with varying risk/cost ratios—giving you the analytical data to choose a solution that maximizes performance while minimizing costs.
Your third-party logistics (3PL) and adherence to Good Distribution Practices (GDP) play a key role in protecting your therapeutic in transit. But often, the logistics network for an approved therapeutic isn’t optimal or doesn’t yield the expected performance in the field.
Modality Solutions can assess your logistics network design and recommend opportunities to improve it—reducing risks to your product and patients and driving down your supply chain costs. Our logistics network design services can include identifying risks and mitigation measures, collecting current shipping lane data, developing a validation master plan, evaluating supply chain partners, developing partner quality and service level agreements, creating new SOPs, and training your staff on those new procedures.
We’re also equipped to provide logistics network design help in fast-turnaround Emergency Response situations like infectious disease outbreaks-supporting our Public Health clients by ensuring the intended facilities are prepared to store and distribute temperature-sensitive vaccines and other therapeutics in difficult environments.
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