Biorepository and biobanking services
With over 40 years of expertise in cold chain management and a global network of trusted partnerships, we safeguard the integrity of your ultracold supply chain, providing real-time monitoring and assurance for dependable sample storage.
Our biorepository services support the storage of over 100 million samples worldwide. From small biotechs to large pharma companies, we serve a broad range of clients, offering expertly managed biorepository services for samples across ambient to cryogenic temperatures.
Our comprehensive services and solutions go beyond simple storage, providing industry-compliant environments where samples are cataloged, tracked, and securely maintained—saving you time and resources, as well as providing peace of mind at every step.
Comprehensive GMP Biorepository Solutions
Our full-service GMP biorepositories provide secure, customizable short- and long-term storage solutions to support all phases of clinical trials and commercial specimen management.
With 14 global cGMP-compliant facilities, we offer storage solutions across a broad range of temperatures and conditions—from ambient to vapor phase and liquid nitrogen—including:
- Ambient and controlled room temperature
- Refrigeration/freezer (+5°C to -20°C)
- Ultra-low freezer (-40°C to -80°C)
- Liquid nitrogen (-150°C to -196°C)
Our state-of-the-art facilities are specifically designed to accommodate diverse biospecimen types, including patient materials (e.g., biopsies, blood, urine) and critical manufacturing materials (e.g., biologics, plasmids, viral vectors, and drug products).
Due to our flexible approach, every project benefits from a tailored biorepository sample management plan that ensures a precise chain of custody, continuous monitoring, and easy accessibility for testing, compliance, drug safety, or clinical analysis.
We also offer value-added options, including sample processing labs, cold chain logistics and distribution, and cold chain packaging and labeling for clinical trials and commercial products. It’s our goal to deliver a comprehensive, personalized solution that meets your needs.
With advanced monitoring, automated alerts, and backup power, our global facilities mitigate risk, ensure security, and safeguard materials at cold, ultracold, and cryogenic levels.
Our centralized approach simplifies the storage, management, and distribution of temperature-sensitive therapies, providing reliable and efficient solutions you can count on.
- 24-hour temperature and humidity monitoring for optimal conditions
- Facilities equipped with uninterrupted power supply (UPS) systems and multiple backup generators
- On-call staff available day or night to address any temperature deviations
- 21 CFR Part 11-compliant inventory management system with near-real-time online visibility through a secure access portal
By validating our processes and qualifying our equipment, we minimize risks, preserve material integrity, and consistently meet regulatory requirements throughout the entire chain of custody. Our fully validated tanks and freezers are built to perform under a wide range of environmental conditions and comply with diverse industry standards. This guarantees adherence to stringent temperature, humidity, and uniformity specifications.
- Deliver solutions for controlled-temperature pack-outs to safeguard material integrity
- Test dry shippers with mock material loads in various thermal environments
- Provide comprehensive qualification data reports in a timely manner
Continuous monitoring system
Our validated continuous monitoring system provides 24/7/365 data, reporting, and alarms to protect your critical materials. These systems are tested for FDA 21 CFR Part 11 compliance, ensuring accurate, ongoing monitoring of all freezers, refrigerators, reach-in and walk-in units, and ambient storage areas.
Quality management system
Our comprehensive and integrated quality management system is aligned with regulatory cGMP requirements and industry best practices. Our quality policies and standard operating procedures are implemented across all global facilities, ensuring uniformity and compliance with customer and regulatory requirements.
Regulatory compliance
Our quality management system adheres to current cGMP guidelines and complies with regulatory authorities locally and globally.
- US cGMP: Food and Drug Administration (FDA)
- 21 CFR 210, 211, 820, 1271
- 21 CFR Part 11 and Part 58 (where applicable)
- EU cGMP at our US, NL, and UK facilities
- In-house QP release at NL and UK facilities
- ISO 9001:2015 certified (UK site)
- Audited HCT/P establishment
- Employees receive regular training to maintain compliance, particularly for clinical trial support
A global network like no other
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The industry’s largest portfolio of fully owned cGMP facilities
With our expansive global network, we provide access to the industry’s largest portfolio of fully owned cGMP facilities. Strategically positioned worldwide, these state-of-the-art, redundant facilities enable us to deliver uninterrupted, high-quality services to customers globally.
Our network can scale staffing support to manage higher-volume work, making us ideally suited for large studies, such as flu vaccine trials, which require substantial capacity on short lead times.
By leveraging our substantial capital investments and operational agility, we efficiently and effectively meet the demands of large-scale projects, offering clients the reliability and flexibility they need to succeed as they bring their innovative therapies to market around the world.
Experience biobanking in action: The step-by-step process for securing your samples
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