Biological Sample Management

BioRep is a Biological Resource Center within the Sapio Group, specializing in the collection, processing, cryopreservation, storage, and distribution of biological samples for research institutions, universities, public and private hospitals, pharmaceutical companies, and biotechnology organizations.

Founded in 2003 and located within the DIBIT2 Biotechnology Center at San Raffaele Hospital in Milan, BioRep ensures the highest standards of quality, safety, and traceability in biological sample management, with an overall storage capacity of up to 10 million samples.

Each sample is processed in UNI EN ISO 9001:2015-certified and SMeL-accredited laboratories, where the following activities are performed:

• Cell line preparation and maintenance
• Nucleic acid extraction
• Genetic analyses and molecular testing
• Cellular biology, molecular biology, and microbiology services

These services support research projects, observational studies, preclinical and clinical trials across multiple therapeutic areas, particularly oncology, neurodegenerative diseases, and rare disorders.

Samples are stored under conditions ranging from controlled room temperature to cryogenic temperatures between -80°C and -196°C, using cryogenic storage systems and continuously monitored mechanical freezers. Our infrastructure ensures 24/7 monitoring of all critical parameters, with continuous data logging, real-time alarms, redundant systems, backup procedures, on-call support, and business continuity measures to guarantee the highest level of security and quality for stored biological materials.

Sample management services also include:

• Design, production, and management of collection kits (more than 500 kits per day)
• Ambient and temperature-controlled transportation, including customs documentation management
• National and international distribution
• Support for global research networks
• Comprehensive clinical trial support through Advice Pharma Group, the CRO acquired in 2022

Thanks to advanced infrastructure, highly qualified personnel, and state-of-the-art monitoring systems, BioRep has become a leading reference partner for the integrated and secure management of biological samples, contributing to the advancement of scientific research and biotechnology innovation in Italy and worldwide.

BioRep also operates an AIFA-authorized GMP Pharmaceutical Depot for the storage of sterile active pharmaceutical ingredients and biological materials, including Master Cell Banks (MCB) and Working Cell Banks (WCB). Cryogenic equipment and monitoring systems are fully validated, ensuring 24/7 control and complete traceability through LIMS technology. The facility supports multiple storage temperature ranges, from -20°C to -196°C, through certified nitrogen vapor systems and mechanical freezers, guaranteeing stability, compliance, and product integrity for pharmaceutical and biotechnology applications.