Securing the preservation of your biological assets

We specialize in preserving a wide range of biological materials, including, but not limited to, human tissues and cells, clinical trial samples, master cell banks, and pharmaceutical products.

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EU Licenced Tissue Establishment

Biostór Ireland is a certified Tissue Establishment (TE) in accordance with EU Directive 2004/23/EC (Irish Law S.I. NO. 158 of 2006). Our licensure encompasses the import, storage and distribution of human tissues and cells across all 27 EU member countries. Our processes align with US FDA Good Tissue Practices (GTPs), ensuring the highest quality standards for cell therapy products and ATMP under precisely controlled conditions.

Our operations are fully authorized by the Health Products Regulatory Authority (HPRA) of Ireland. Regular biennial inspections validate our procedures, assuring meticulous accuracy, compliance, and traceability. We adhere to a Quality Management System (QMS) based on ISO 13485 and comply with all necessary principles of the GXPs encompassing Standard Operating Procedures (SOPs), guidelines, training programs, and records. A designated Responsible Person oversees our qualified storage equipment, working environment, and processes.

Gene & Cell Therapy Storage

Biostór employs advanced techniques for the long-term storage of cell therapy products. Our Liquid Nitrogen (LN2) vapor vessels provide optimal conditions, and dedicated quarantine vessels are available as needed. Strict change control, variance control, and CAPA procedures, reviewed and approved by the Responsible Person, ensure the precision of our equipment, systems, and processes.

We proudly manage the national inventory of Bone Marrow (BM), Donor Lymphocytes, and Peripheral Blood Stem Cells (PBSC) for cancer patients, alongside our stem cell preservation services.

Master Cell Banking

For pharmaceutical production and testing, Biostór Ireland stores GMP-certified Master Cell Banks (MCB & WCB) in validated LN2 Vapour Freezers at -196°C. Our storage capabilities extend to small cell banks and large cell banks containing thousands of vials.

The Master Cell Bank (MCB) and Working Cell Bank (WCB) are irreplaceable assets, requiring safeguarding against loss and degradation. Unforeseen events can endanger years of work.

Entrust us with your valuable resources, and together we’ll ensure their preservation.

Safeguarding Your Assets

Biostór introduces GMP-compliant safe deposit services for safeguarding Master Cell Banks (MCB), Working Cell Banks (WCB), and other valuable research assets. Laboratories, and research institutions can store backup copies with confidence, ensuring continuity in emergencies.

Tailored Sample Storage Solutions

Selecting appropriate sample containers is crucial for maintaining biospecimen integrity during transport and storage. Our solutions optimize sample quality, minimize variability, and adhere to regulatory standards. From -196°C to room temperature storage, Biostór offers a diverse range of sample management solutions.

Innovative Sample Management

Biostór employs cloud-based sample management for enhanced collaboration and real-time data sharing. Accessible anywhere, anytime, this powerful tool facilitates clinical site procurement, storage, and testing oversight. Our system conforms to regulatory standards, offering FDA 21 CFR Part 11 and GDPR compliance.

Why choose Biostór?

EU-licensed Tissue & Cell Establishment for Cell Therapy products
GMO-approved facility
ABP-approved storage and distribution facility
Qualified and validated equipment
24/7 real-time monitoring
Stem cell banking and preservation
Compliant MCB & WCB storage services
ISO 13485-compliant SOPs
Diverse temperature range: -196°C, -80°C, -20°C, 2-8°C, and controlled room temperature

Our services support your Disaster Recovery Plan, facilitate EU collaborations, and safeguard against regulatory changes. Partner with us to ensure the continuity and security of your valuable biological materials.