MRIGlobal offers full-service repository management to pharmaceutical and biotechnology clients. Many virtual and even large pharma customers rely on MRIGlobal to handle their sample management. Virtual organizations lack the infrastructure and large pharma clients benefit from an agile responder. From drug substance storage and distribution, clinical trial management and stability offerings with a huge variety of storage conditions, we have developed a process and tailor our operations to fit the specific and unique needs of each client.
MRIGlobal offers a customized operational plan to each pharmaceutical client in terms of logistical support of key starting materials, drug substances and drug products.
Our clinical trial logistical support includes storage, inventory management, importation activities, shipping, supply management, receipt and distribution, restocking, disposal, clinical label design and production, custom kitting, and preparation of blind samples. We can customize our stability facility to suit a variety of storage conditions. For example, we can meet the Moderna COVID-19 vaccine storage requirements of an environment between -15 to -25°C without the use of dry ice and protected from light.
Sample Storage Offerings
We are licensed for drug sample distribution and we maintain customizable storage facilities. Our licenses include:
- DEA licenses for schedule 3, 3N, 4, and 5 controlled substances
- Third Party Logistics Provider license
- Drug Distribution license
Because the majority of our work is under US Food and Drug Administration (FDA) compliance, FDA and client representatives regularly audit our facility.
MRIGlobal customizes operation areas based on the specifics of each client’s material needs. We provide dedicated space for the receipt, management, quarantine, dispensing, labeling, packaging, and distribution of materials.
Storage facility specifics
Through continuous improvement, our facilities maximize workflow efficiency and maintain the integrity of client products. All of the work done in our storage facility is performed in strict accordance with federal regulations. In addition, the facility is equipped with:
- 10,000 ft2 of secure storage space
- Validated and temperature mapped storage
- -150°C; -80°C, -30° to -10°C; 2° to 8°C; controlled room temperature (CRT) and ambient storage conditions with a continuous monitoring and alarm system
- Inert fire suppression system
- High potency containment areas
- Automated 72-hour backup generator to support the entire facility
Drug sample distribution
A great storage solution is only half of the story when it comes to the logistical success of your pharmaceutical materials. They need adequate and efficient distribution. In the past eight years, our team has shipped more than 1,500 drug sample deliveries (without incident) to both domestic and international destinations.
Vaccine cold chain
What’s a cold chain? The vaccine cold chain is a network that includes cold rooms, freezers, refrigerators, cold boxes, and carriers designed to keep vaccines at their optimal temperature throughout the entire process.
Vaccines require strict temperature control to ensure their efficacy. Both COVID-19 vaccines by both Moderna and Pfizer–BioNTech require ultra-cold temperatures to maintain their efficacy. The Johnson & Johnson COVID-19 vaccine vials may be stored under refrigerated conditions until the expirations date before the vials are punctured.
Logistical support plays a vital role. Once the vaccine doses are produced, the units are transported to the health centers or immunization programs for distribution. Once they arrive, they need to be kept at the recommended storage conditions until they are administered.
Why do some vaccines need to be so cold?
Moderna’s COVID-19 vaccine needs to be kept at -20°C. Pfizer’s COVID-19 vaccine is one of a handful of vaccines that require ultra-cold temperatures at -75°C.
Why so cold? Simply put, the Moderna and Pfizer vaccines must be kept cold to preserve the integrity of the mRNA. Should it remain warm too long, the material falls apart and loses efficacy.
Our ultra-cold chain
MRIGlobal has a solution with our 15 ultra-cold freezers. Our ultra-cold freezers can reach temperatures as low as -86°C. We manage these with our validated inventory management system to ensure all materials are kept at the proper temperatures. We can store up to 200,000 doses of vaccine in our ultra-cold freezers.
Pharmaceutical Repository Frequently Asked Questions
What makes MRIGlobal’s repository services stand above the rest?
There are a few things that stand out when a new client partners with MRIGlobal. MRIGlobal’s customized approach for each program makes us unique. Our synergistic approach with dispensing and testing is a tremendous value that saves our clients time and money. Finally, our quality stands out, giving all stakeholders confidence that the job will be done right the first time. A larger repository facility may say, “This is how we do it,” whereas our client can say “This is how we’d like it done.” As long as MRIGlobal is compliant with regulatory requirements, we are extremely flexible in meeting the program needs. Our dispensing and analytical streamlines operations for the client. This avoids additional risky unit operations such as moving material from a storage facility to a dispensing facility to a testing facility, especially if the materials are under different quality systems. Our Quality group is second to none. We have passed numerous FDA, DEA and client audits.
Are repository contracts month-to-month or signed for a certain duration of time?
We typically have clients sign annual contracts. However, we will accommodate shorter contracts when requested.
Does MRIGlobal offer sample data or any kind of advice?
MRIGlobal’s repository services alone do not offer sample data, but we can distribute samples to our analysis staff for more information. We offer advice based on our experience. For example, we could recommend the right label size to fit information about your sample. We can also help with kit design by finding the best ways to combine vials, syringes, and other dosing tools with their samples.
How do you know which stability parameters I need for my samples?
Stability protocols are established by our analytical staff working in conjunction with our client. The analytical staff then provides that information to us, and we store the sample based on their recommendations and the appropriate regulatory authority.
Can MRIGlobal distribute my samples?
Yes! MRIGlobal staff can distribute your samples. We have a variety of shipping options available depending on your specific needs. Some samples can ship in a standard corrugated box. Others may need specialized shipping containers for dangerous goods or controlled temperatures, both of which we offer.
Our entire staff is trained in International Air Transport Association (IATA) regulations for dangerous goods shipments. We also have connections with several shipping companies for temperature-controlled shipments, which provide temperature loggers so you know your samples stayed in-range during the process. We even have Quality Agreements in place with specific carriers.
Do you provide repository services for anything outside of pharmaceuticals?
Yes, our offerings include much more than a pharmaceutical repository for clinical trial support and stability study storage. A large portion of our work is drug substance and reference standard storage and distribution. Our repository services include pharmaceutical (chemical and biological) samples, reference standards, and starting materials. If you have any questions on whether your samples will be a good fit for our facility, schedule a time to visit our repository.
Learn more about the pharmaceutical repository and storage at MRIGlobal
For more than 75 years, MRIGlobal has advanced scientific research across a variety of industries. We focus on supporting better health outcomes on a global scale. For us, it’s not simply about science; it’s about the people who make it all happen.
Our solution-driven approach drives solutions for even the most complex situations. Through our dedication, we can solve any technical problem.
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