Allele Biotech operates a cGMP-compliant cell banking system, meticulously following a set of well-established and rigorous SOPs.
The storage units are equipped with two liquid nitrogen tanks: one in active use, and the other as a backup. If the pressure in the primary tank falls below the alert level, the secondary tank will automatically switch on. Simultaneously, our storage units are equipped with an independent Continuous Monitoring and Alerting system, which is provided and validated by Vaisala. The alerting system triggers when the temperature falls below the predefined alert level.
This cGMP cell banking system is fully integrated into our Preventive Maintenance program within our electronic Quality Management System, ensuring not only the initial setup but also the ongoing operation and maintenance adhere strictly to cGMP requirements.
The cells are stored in the gas phase within a specified temperature range. We offer compatibility with a variety of storage containers, including cryogenic vials, bottles, and bags of various sizes.
If your projects are at the pre-clinical or early clinical phases, Allele Biotech’s cGMP banking service can significantly save your budget and time associated with setting up, operating and maintaining a cGMP banking unit alone. If you are interested in this service, please contact us via email at firstname.lastname@example.org.