BioStorage Solutions

cGMP storage across four facilities

Masy BioServices offers premium cGMP storage

Like so many of Masy’s Solutions, our cGMP Storage Solutions started due to customer needs. Over ten years ago, our validation customers began asking if we could store their products rather than build and manage onsite storage facilities. This request led to us planning the next phase of our business—off-site cGMP storage.

We knew we had the cGMP knowledge and experience with FDA regulations and was a matter of us acquiring and equipping the right facilities quickly. Today, we have four premier cGMP storage facilities in the United States and are the industry leader in the field.

Offsite cGMP Biostorage Solutions

Controlled/Ambient Storage Solutions

Shelf-stable materials, medical devices, and retains can take up significant space at your in-house storage facility. Masy’s controlled temperature and ambient storage spaces have specific temperature ranges to accommodate your specifications: Real-time Aging (20°C to 25°C), Real-time Shelf Life (20°C to 30°C), and Ambient (15°C to 30°C).

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Stability Storage Solutions

When you need to store your pharmaceuticals, medical devices, APIs, or other biopharma materials, the most important objective is to ensure the materials remain in their original condition. Our stability storage chambers are flexible to meet your specific requirements while meeting ICH requirements.

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Refrigerated Storage Solutions

We store your products at optimal temperatures and tight tolerances, from 2°C to 8°C, to ensure stable environmental conditions for your critical materials.

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Freezer Storage Solutions

Our freezer storage spaces offer secure freezer storage at -20°C, -22.5°C, -30°C, -40°C, and more. Masy provides reliable freezer storage solutions for APIs, biofluids, FBS, research samples, stability samples and more so you can prevent any degradation or product loss.

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Ultra-Low Freezer Storage Solutions

Ultra-low freezer storage for temperature-sensitive materials is essential to maintaining the viability of biologic materials and samples. We store your drug products, substances and cells at a stable, ultra-low freezer temperature of -60°C or -75°C.

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Cryogenic Storage Solutions (LN2)

Extremely low temperatures suspend all biological activity and preserve your products for long-term storage. Masy offers cryogenic storage solutions at vapor phase colder than -135°C with dedicated and shared space for master and working cell banks and biologic samples.

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Peace of Mind That Your Products Are Safe

Operating a life sciences company is an expensive venture; whether you are a small start-up or a large pharmaceutical or biotech company, you constantly deal with ever-increasing costs in resources, services, and space. Space is precious and can fill up quickly when storing cGMP products or materials on site.

Not only is onsite storage costly, but it’s also complicated and risky. You must consider cGMP protocols, regulations, and potential issues such as losing power, security, systems breaking, and developing trained staff. When you select off-site cGMP biostorage, you free up precious real estate for core business needs, and you save on those unforeseen projects. When you use Masy’s biostorage, the burden shifts off you, and we provide peace of mind that your materials are safe and secure.

We treat your critical materials as if they were our own, staying compliant with SOPs, specifications, and tolerances. We know that keeping your materials secure and stable is critical to your bottom line and patient safety. You can feel confident that the materials will remain in the condition you require at any of Masy's biostorage facilities.

Are there gaps in your storage plan?

Need for overflow storage space

Inadequate environment controls

On-site resource restraints

Product security and stability risk

Lack of redundancy

No disaster recovery plan for storage

Masy fills the gaps.

Offsite storage space and validated cold chain transportation

24/7 temperature and humidity monitoring and controls

Precise temperature parameters, from 70°C to -135°C

Industries We Serve

  • Group 48

    Pharmaceutical

  • Group 49

    Biotechnology

  • Group 47

    Life Sciences

  • Group 46

    Medical Device

Industry-Leading Standard Operating Procedures

As a cGMP biostorage facility, we are regularly audited by our customers. Our audits reassure our clients that we follow strict procedures and that our team of experts knows how to keep your materials secure in your requested condition.

In addition to our commitment to quality in service and products, our biostorage customers appreciate the following industry-leading processes and protocols:

If street power fails, Masy has two high-capacity backup generators. Each is capable of running our entire biostorage operation with auto switch-over. The -75°C, -60°C, and -40°C walk-in chambers have triple-redundant cooling systems, dual compressors, and, alternatively, LN2. In addition, our GMP ambient storage warehouses have redundant heating and cooling systems. We ensure your sensitive products are protected 24/7/365 by using a combination of swipe cards, limited access, Cyber Locks on all chambers, and video surveillance monitoring with security. This extensive protection allows our customers and our Masy staff to sleep well at night.

Our multiple monitoring systems continuously monitor and scrutinize temperature and RH conditions in our storage rooms and chambers. We also have two independent validated monitoring systems and three monitoring sensors installed in each chamber and room, based on validation mapping studies. If sensors begin to drift, alarms instigate, noting a performance change, so there is sufficient time to intervene before an out-of-tolerance situation occurs. We document all alarms, and customers are welcome to view reports.

In the rare event of an alarm, we take care of it immediately. We have a call list supported by trained technicians with backup assistance. These technicians follow written procedures to solve the problem within the chamber first, and if necessary, relocate your product to a safe environment while repairs are underway.

We also maintain and monitor conditions in the biorepository common areas. Like the rest of our chambers, we have performance alerts set up in those areas and on-call staff ready to address any occurrence.

Masy also helps our customers create the best possible conditions for packaging and transportation. We care about the safety of your product long before it gets here and long after it leaves. That’s why we perform mock transportation runs with our ultra-low freezer storage and packaging equipment. We can find a solution for every customer transportation situation with our extensive inventory of traditional shippers and dataloggers and the Masy-created “Masy Transporter” to deliver frozen products. We have truly planned for all scenarios and situations, which is why we are a proud leader in cGMP biostorage.

At Masy, we are committed to integrity and full transparency, which is evident when our customers audit our facility. During audits, we encourage you to review documentation, practices, and processes. You can also meet our team of biostorage subject matter experts and ask questions and provide feedback. These team members undergo extensive training to bring your product into our facility, maintain requested temperatures, ensure top security measures, and prepare your product to move to its next destination. We continuously review and update our processes to ensure we are employing best practices.

For nearly 40 years, we have made it our mission to be more than a service provider and more of a valued partner to our customers. To us, that means finding solutions to customers’ problems with excellent service and quality products. Our biostorage service began as a customer request and is now one of our key offerings, proving that we respond when there is a client need. And we respond by raising the bar of excellence.

BIOSTORAGE RESOURCES

Biostorage capabilities and conditions brochure

cGMP Biostorage Brochure

Masy's off site biostorage provides you with security and peace of mind, knowing that your critical materials and samples are protected at all times.

Developing and manufacturing the next life saving drug or medical device is part of your job. Managing...

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Selecting Your Off-site GMP BioPharma Storage Provider

Selecting Your Off-site GMP Storage Provider

This paper discusses what to consider when selecting a vendor.

Off-site storage of GMP biological/pharmaceutical products and medical devices can be a critical resource for biopharma companies. There are many important factors to...

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Contact Us

Get in contact with our biostorage team so we can discuss your next storage solution!