Overview

Regenerative medicines are temperature-sensitive and inherently fragile. They require a specialized approach of cold-storage temperature control, transport, and scheduling to maintain ultimate product integrity.

These therapeutics undergo rigorous quality control and sample handling procedures throughout manufacturing and storage. Researchers must have confidence their valuable cells will not be mishandled or exposed to damaging warming events.

Best-in-class sample storage and intralab sample transport and logistics ensures security and quality control is maintained.

Pharmaceutical companies and contract manufacturers trust Brooks to support discovery and production of regenerative medicines and cell therapies. Provider hospitals partner with Brooks to track sample management, consent, and sample requisition history. And patient hub services benefit from an integrated cryostorage and logistics platform.

Key Processes
  • Donor cell and tissue harvesting Cells and tissues must be transported to the lab for storage according to rigorous SOPs. Brooks offers sample collection kits, transport services, and automated cryostorage solutions to meet these requirements.
  • Cell isolation and purification Samples of starting cell population must be preserved, collected, and managed under precise temperature parameters for in-process testing. Our proprietary offsite and onsite sample management, sample transport, and cryostorage solutions facilitate this work.
  • Manufactured therapies Besides retaining master cell samples, Brooks also works to preserve finished product with onsite and offsite solutions with transport, cryogenic sample storage, and an unmatched level of documentation and temperature stability. 
  • 21-CFR-11 sample chain of custody and reporting Automated storage solutions are IQ/OQ/PQ validated to help mitigate supply chain risks. Informatics are integrated with cryostorage solutions to provide reporting and documentation for all levels of storage and monitoring.