Clean Mails – June 2023
Integrated solutions for cell and virus bank manufacturing and characterization
As a GMP-licensed organization, Clean Cells has a stellar track record in biosafety testing and characterization services for various biopharmaceuticals since 2000. Moreover, the company excels in cell and virus bank manufacturing services to produce starting materials for vaccines, monoclonal antibodies, cell and gene therapies, and other biological products for human and animal health.
Cell and virus bank manufacturing in state-of-the-art facility
With a focus on cell banking, Clean Cells offers a fully integrated solution for cell bank manufacturing and characterization, backed by global partnerships. These cell banks serve as essential building blocks in biomanufacturing strategies, ensuring safety and stability through robust processes, and significantly influencing the success of manufacturing projects.
Clean Cells shows over 20 years of experience in handling diverse cell lines, including mammalian, avian, and insect substrates, positioning itself at the forefront of the industry. The company goes beyond cell banking by providing additional virus bank manufacturing services through its BSL2 and BSL3 capabilities, catering to sponsors involved in virus-based manufacturing projects.
Operating 9 state-of-the-art GMP cell and virus bank manufacturing suites in a brand-new facility, Clean Cells accommodates various suspension and adherence-based technologies. These BSL2 suites undergo continuous environmental monitoring and equipment surveillance to meet regulatory expectations.
Static cell culture methods, such as flasks and multilayer vessels for adherent cell lines, as well as shaking cell culture techniques utilizing spinner flasks, erlen flasks, and wave systems for suspension cells, are facilitated within the facility.
Clean Cells offers cell and virus bank manufacturing services in both non-GMP and GMP environments, supported by an advanced Quality Management System (QMS) to maintain traceability and proper documentation.
Characterization for integrated cell and virus bank manufacturing services
The company addresses the need for comprehensive characterization post-cell and virus bank manufacturing by providing a complete suite of tests that meet worldwide regulatory requirements. Our 200+ tests encompass sterility, mycoplasma, mycobacteria, detection of adventitious agents, retrovirus analysis, identity verification, and genetic stability assessment. As a one-stop shop for the production and quality control of these banks, Clean Cells optimises lead times to speed up your projects.
Storage post-cell and virus bank manufacturing
Clean Cells recognizes the significance of secure long-term storage for valuable cell and virus banks. Therefore, it offers reliable long-term storage services for GMP and non-GMP bank preservation, featuring shared or dedicated storage options, periodic storage reports, continuous temperature monitoring, an externalized alarm system, and storage in a secured and separate areas with backup containers. This ensures the preservation of quality attributes of material produced during cell and virus bank manufacturing within coherent QMS and regulatory expectations.
Integration into the Clean Biologics group
The collaboration between Clean Cells and Naobios, both part of the Clean Biologics group, enhances the range of cell and virus bank manufacturing services provided. Naobios specializes in GMP virus-based process development and manufacturing services, seamlessly integrating with Clean Cells’ expertise. This collaboration creates an integrated solution, enabling Naobios to take up cell and virus banks in cGMP conditions for further manufacturing, including the production of virus-based products and clinical materials up to Phase III.
Clean Cells’ vast expertise, cutting-edge facilities, comprehensive characterization services, and secure long-term storage solutions establish it as a trusted partner for integrated cell and virus bank manufacturing and characterization.