3 Services Your Biopharmaceutical Supply Chain Partner Should Offer

When it comes to choosing a cell and gene therapy shipping partner, not all providers are created equal. To select the best partner for your organization, it's important to consider how their solutions will meet your needs for today and in the future.

As the premiere provider of temperature-controlled supply chain solutions, Cryoport Systems has extensive experience serving the cell and gene industry. With over 650,000 shipments across 150+ countries, we know what it takes to meet the needs of those companies producing lifesaving therapies. For those amid the decision-making process, here are three key services that can help you determine if a supply chain partner is the right for your organization.

1. Shipper Requalification

When it comes to material that can't be replaced, it's vital that it's packed in a shipper that offers optimal product security. But how do you know if a supply chain management partner takes shipper compliance seriously? Not every company has invested the resources into shipper requalification which means that your materials could be at risk of contamination or damage even before the transportation journey has begun.

Shippers are qualified by the manufacturer as they leave the factory, but being that they are exposed to many external factors, the need for continued recertification is paramount to mitigating risk. The best supply chain partner will have the tools and procedures in place to bring certainty to your shipping process. Cryoport Systems' requalification process adheres to ISO 21973, the standard that ensures life-saving therapies are always transported consistently. Our requalification processincludes processes such as:

• Veri-Clean® - the industry's first and only validated cleaning and disinfection process.
• Physical suitability tests - a visual inspection of the internal and external conditions of the equipment to guarantee it's suitable for continued use.
• LN2 capacity checks- tests the shipper's capacity for maintaining the proper liquid nitrogen levels throughout transit.
• Minimum required hold time threshold - ensure that our shippers can maintain a 10-day dynamic hold time.

Our qualification service is based on specific payloads and may not match up to your exact payload. Additionally, we utilize our Advanced Therapy Shipper™ (ATS)product line, a first-of-its-kind fleet, to exclusively ship cell and gene materials for both clinical and commercial therapies. In doing so, we cut down the risk of contamination from other non-human-based materials.

2. Risk Mitigation

There's not a 100% guarantee that shipments of all kinds won't encounter bumps along the way. Even so, a good supply chain management partner should be able to mitigate those risks by suggesting the best path to take for your shipment to reach its destination compliantly. However, not every management partner has the resources to obtain this information.

Cryoport Systems' experience and knowledge allows us to thoroughly mitigate shipment risk. When a trial has specific needs, our Consulting team works with our clients collaboratively, taking an unbiased approach to analyzing historical Cryoportal data relative to the specific lanes and selected carriers. One of the many benefits of working with our Consulting team is the Shipping Risk Assessment Report, which includes:

• Metrics, KPIs, and supplemental information to guide shipping decisions.
• Specifics on shipping lane options that can help eliminate options or develop lane procedures.
• Analysis of past shipment handling such as tilt/handling at airports, shock events, and temperature consistency on route.
• Measurement of each shipper's Nitrogen Evaporation Rate (NER) to determine its true anticipated dynamic hold time.

With this information, our team can confidently recommend a transport plan with risk-mitigation at the forefront of considerations.

3. Project Scalability

Clinical trials can take years to complete. Many times, the supply chain needs of an organization will change as the trial progresses through each clinical phase. Instead of contracting with different supply chain partners for the progressing trial phases, you want a partner that can scale their services alongside your therapies. Or otherwise put, the best temperature-controlled supply chain solutions partner will have products, procedures and services that will grow with you.

Supply chain project scalability doesn't just mean the ability to progressively ship large quantities of materials. It starts at the beginning with consulting services that can personalize shipping solutions to fit your needs. Cryoport Systems' addition of our BioServicessolutions extends our operations to all parts of the supply chain. We offer GMP-compliant storage solutions, packaging and labeling customization, drug return and destruction, and more. Our BioServices solutions coupled with our domestic and international logistics abilities means that we can handle all phases of your clinical trials from phase I to commercialization.

Trust Cryoport Systems to be the best supply chain partner for the cell and gene therapy industry and for you. For more information on how our services will meet your needs, reach out to usor find more informationon our website.

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