La revue scientifique trimestrielle

Clean Cells, a GMP-licensed company, is a world-renowned expert providing biosafety testing and characterization services for all types of biopharmaceuticals since 2000. The company has also a long-standing background providing manufacturing services to generate starting material further used to produce vaccines, monoclonal antibodies, cell and gene therapies, and other biological products used in human and animal health.

Our expertise extends to cell banking: Clean Cells thus offers a fully integrated solution for cell bank generation and characterization. It is supported by countless partnerships around the world.

Biological products are complex and requires hands-on expertise to ensure that they meet the required safety and stability through robust processes. Cell banks (RCB, MCB, WCB) are essential building blocks of any bioprocess strategy and their quality often shapes the future of successful manufacturing projects.

With 20+ years of experience handling the most diverse cell lines, Clean Cells is at the forefront of the industry. We have worked with hundreds of cell lines including mammalian, avian and insect substrates.

Additional virus banking services through our BSL2 and BSL3 capabilities can be made available to sponsors leading virus-based manufacturing projects.

Our facility consists of 5 state-of-the-art GMP manufacturing suites: the BLS2 grade A-in-C laboratories undergo environmental monitoring at critical steps while equipment is continuously monitored to prevent any defect and meet regulatory expectations.  Equipment allows for static cell culture (flasks, multilayer for adherent cell lines) or shaking cell culture (spinner and erlen flasks, wave system for suspension cells).

Our cell banking services may be provided in non-GMP or GMP environment depending on the stage of your product and comes with fully optimized planning from initial RCB testing to cell bank release. An initial feasibility batch allows for the proper method transfer from sponsor, optimization of culture parameters, and provides starting material to process development.

Banking is supported by an advanced QMS which ensures traceability and documentation at each stage of production and according to regulatory requirements.

Cells banks are usually released through minimal testing and requires additional testing in a separate facility.

Clean Cells offers a complete set of tests for the full characterization of cell banks according to GMP or non-GMP requirements, thus building a one-stop-shop solutions for sponsors. Cell banks can undergo testing as soon as they become available internally: timelines are optimized and characterized banks can be used directly in your manufacturing process.

Characterization services include:

• Sterility
• Mycoplasma
• Mycobacteria
• Non-specific Adventitious Agent Detection (In-vivo, in-vitro)
• Specific Adventitious Agent Detection (human, bovine, porcine and other animals)
• Retrovirus (electron microscopy, infectivity assays, qPERT)
• Identity
• Genetic Stability (Karyotype, Gene Copy Number,…)

A portfolio of 200+ assays in biosafety, purity,identity and potency is made available to sponsors in GMP or non-GMP settings and may be used in bespoke testing strategies.

Cell banks are valuable material and require secured storage to ensure stability over time.

Clean Cells offers long-term storage services for GMP and non-GMP bank preservation with the following specifications:

• Shared or dedicated storage
• Periodic storage report
• Continuous temperature monitoring
• Externalized alarm system
• Storage in a secured and separate area
• Backup containers

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Please reach out to the team for additional information.