The complex, live structure of biological material is highly sensitive to environmental changes and requires a comprehensive supply chain. This type of material not only necessitates temperature controlled storage and handling, it must also be closely monitored to ensure the material maintains its stability and viability.
Whether you are preparing vaccines or personalized gene therapies, or safeguarding cell lines for future discoveries, we are committed to protecting your irreplaceable biological materials.
We offer purpose-built facilities, liquid nitrogen-equipped vehicles, and a global network of logistics experts to transport, store, and protect your materials in ambient to cryogenic conditions. Our inventory management system allows our customers to have access to their data and inventory online 24 hours a day, 7 days a week. It is validated, 21 Code of Federal Regulation (CFR) Part 11 compliant, and is easily configurable to client specifications, giving customers the ability to easily share information designed to accelerate lifesaving discoveries.
Our global, comprehensive and integrated Quality System policies and standard operating procedures (SOPs) follow current Good Manufacturing Practices (cGMP) guidelines and are implemented across our facilities, ensuring uniformity and adherence to customer and regulatory requirements.
As the leader in managing critical biological material, we ensure a seamless workflow which connects the sponsor, bio-manufacturer, clinical center, and patient in a well-coordinated chain of custody. Our state-of-the-art infrastructure and SOPs allow us to develop customized storage and packaging configurations for a multitude of biologics, including monoclonal antibodies and vaccines. Upon arrival at our facility, we can freeze biological material according to manufacturer specifications, and store it under current Good Manufacturing Practices (cGMP) compliant conditions. Through our risk controlled systems, we monitor and track material to ensure that the correct temperature is maintained throughout the chain of custody. Additionally, we are able to receive material under quarantine from the point of manufacture and maintain material in a non-released status.
Sample integrity is essential to the success of every biobanking project. Various types of unwanted pre-analytical variables can be introduced at numerous points in the life of a sample, beginning at the time it is collected, through transport, receiving, laboratory processing, during storage and subsequent retrieval for analysis. With experience maintaining the integrity of millions of samples in our global network of biorepositories, we are the experts in transporting, storing, and handling specialized biological samples and material.
Because temperature is critical to sample viability, our cold storage units are monitored 24 hours a day for both temperature and humidity. Our units have redundant compressors to prevent temperature excursions if the primary compressor should fail, and a monitoring system that notifies personnel, day or night, should the temperature of any unit deviate from its acceptable range. Our comprehensive security system includes intrusion detection alerts and our facilities, including freezers and other cold storage units, are gated with access-only card readers. In the event of a power outage, every facility is equipped with both uninterruptible power supply (UPS) systems and one or more back-up generators.
Contact us to learn more about our Biologics Management services for clinical trials.