Biobanking contains the blueprints to future advanced therapies.
Within a biobank, a diverse range of essential tasks encompasses the collection, processing, meticulous storage, vigilant monitoring, precise data management, and responsible distribution of valuable biomaterials. These activities are carried out in strict accordance with legal, normative, and ethical guidelines to ensure the integrity of the stored materials and their related data.
Despite the existence of an extensive global repository of biomaterials such as vital resources like organs, tissues, blood products, and cells, a substantial portion remains inaccessible for R&D studies and clinical trials research. This need for proper repositories is especially apparent when considering the rigorous requirement standards of GMP-grade work. The most trusted repositories will adhere to the best quality systems, operational protocols, and proficiency knowledge of the personnel involved. All of these aspects significantly impact the capabilities and effectiveness of biobanks and are critical to unlocking the full potential of data stored in these biobanks.
Cryoport Systems offers comprehensive solutions for the management of biological materials performed in line with your specific quality and regulatory requirements. Our biobanking service options can accommodate various types of samples, storage temperatures, and volumes all with safeguards to protect and prevent sample tampering or corruption. At each stage of the sample life cycle, we implement rigorous quality control and traceability for all interventions, ensuring you obtain reliable samples and maintain data of the highest quality.
Our ability to maintain room to cryogenic temperatures during all operations with precise data management is the main strength of our services. The systems we put in place ensure that your samples remain at consistent temperatures throughout their entire life cycle to preserve their integrity and traceability. Delivered in line with GMP, GCP, and GCLP standards as well as ISO 20 387 and ISO 9001, our services comply with pharmaceutical regulatory requirements to meet risk management demands relating to our industry. These safeguards create a unique quality assurance system that provides peace of mind that your materials are always handled safely and compliantly.
Cryoport Systems’ biobanking capabilities:
- Flexible storage capacities for GMP, R&D, and clinical material
- Required temperature ranges to preserve sensitive biological materials from ambient to cryogenic
- Validated IT solution & data management – allows for traceability of the data generated at all stages of the sample life cycle with custom reports provided
- Short to long-term storage duration
- All formats including cryobox, microplate, bag, vial, pouch, slide, etc.
- Temperature tracking and remote alarm
- Highly secure and connected infrastructure with 24/7 on-call personnel for eventualities
Cryoport Systems’ biobanking services extend to:
- GMP-secure storage for master cell banks, working cell banks, drug products, drug substances, and raw material for certain sites
- Strategic global locations in the US and EU
- Clinical Studies
- Scientific Cohorts
- Backup Collection
- Biochemical synthesis
- Blood, serum, plasma, feces, saliva, urine
- Cells, tissues, organs
- Protein, DNA, RNA
- Yeasts, bacteria, viruses, fungi, microalgae
- Biochemical products
- Paraffin blocks, histopathology slides