SO & GMP Cryopreservation
ISO & GMP Biological Material Storage: BioRep’s Complete Solution
BioRep S.r.l., a company of the Sapio Group and one of Italy’s leading biobanking organizations, provides advanced ISO- and GMP-compliant biological storage services, ensuring quality, safety, and traceability in accordance with the highest international standards.
With more than 20 years of experience and UNI EN ISO 9001:2015 certification, BioRep supports pharmaceutical and biotechnology companies, hospitals, research centers, and public institutions.
ISO 9001:2015-Compliant Biological Sample Storage
BioRep operates under a certified Quality Management System that guarantees structured and controlled processes for all storage activities.
Our ISO-compliant storage services include:
- Quality control of incoming biological samples
- Complete digital traceability through an advanced LIMS platform
- 24/7 monitoring of temperatures and storage equipment
- Validated procedures throughout the entire sample lifecycle
- High standards of safety and operational continuity
Through automated monitoring systems and technological redundancy, BioRep ensures the long-term stability, integrity, and reproducibility of biological samples.
GMP Storage: Master Cell Banks, Working Cell Banks and Biological Materials
Since 2017, BioRep has been authorized by the Italian Medicines Agency (AIFA) to provide Good Manufacturing Practice (GMP) storage services for:
- Master Cell Banks (MCB)
- Working Cell Banks (WCB)
- Starting materials for biological medicinal products
Our GMP storage solutions meet the stringent requirements of the pharmaceutical and biotechnology industries through:
- Environmental controls compliant with pharmaceutical regulations
- Documentation aligned with regulatory requirements
- Maximum protection against contamination and process deviations
- Facilities, procedures, and equipment validated in accordance with international standards
These services are ideally suited for companies developing advanced therapies, biological medicines, and investigational products.
Advanced Cryopreservation Technologies
BioRep offers multiple storage solutions designed to ensure long-term sample stability and security.
Nitrogen Vapor Cryopreservation (-20°C to -190°C)
Using patented technologies that ensure temperature uniformity and maximum efficiency.
Temperature-Controlled Freezers and Walk-In Storage
- -80°C
- -20°C
- +4°C
Redundant Infrastructure
- More than 60 cryogenic storage tanks
- More than 35 mechanical freezers
Each storage unit is monitored 24/7 through multi-level alarm systems and emergency power supply solutions.
Disaster Recovery: Guaranteed Business Continuity 24/7
BioRep is the first private facility in Italy authorized by the Ministry of Health to provide Disaster Recovery services for public biobanks.
The service includes:
- 24/7 operational support, 365 days a year
- Emergency transportation and transfer of cryopreserved biological materials
- Emergency management and cold chain protection
- Temporary secure storage during critical events
An essential service for transplant centers, hospitals, and public healthcare facilities.
Why Choose BioRep for ISO & GMP Storage
- More than 20 years of experience in biobanking
- Facilities certified and authorized by ISO, AIFA, and the Italian Ministry of Health
- International-level technological infrastructure
- Advanced LIMS software ensuring complete traceability
- Highly qualified scientific and technical personnel
- 24/7 operational security and monitoring
BioRep is the ideal partner for the safe management, control, and preservation of biological materials in compliance with the standards required by research organizations, healthcare institutions, and the pharmaceutical industry.