Cell banking

Cell bank production is an essential step in the development and manufacturing process of biologics, derived from living cells. Cell banks need to be safe (without any presence of contamination or misidentification), genetically stable and uniform to be used as a starting material to manufacture biologics with a correct level of efficacy. 

An initial master cell bank (MCB) or master cell seed (MCS) is created from a single pool of cells and is extensively characterized and tested for safety and purity. Working cell banks (WCB) are generated from one vial of MCBs during the cell banking process and should reflect the characterization of the entire cell line. 

To ensure the success of cell bank manufacturing, it is important to adhere to strict guidelines and regulations, including Good Manufacturing Practices (GMP) and ICH guidelines Q5A, Q5B and Q5D. This involves using validated methods and qualified equipment for their production, conducting thorough testing and characterization, and maintaining detailed records of the entire process.

With our GMP certified facilities, we offer unique cell banking services in its 8 different suites for manufacturing in campaign.

Cell banking - track record - 2

Cell banking track record

Working with hundreds of cell models in qualified spaces within their GMP environment, Clean Cells has extensive experience in the cell culture production of banks used for the manufacturing of drug product purposes or quality control purposes.

We offer advanced cell banking services to support various R&D and GMP processes for biologics intended for human or animal health. 

We worked with mammalian, insect, and avian cell lines intending for all types of biologics. Our GMP cell banking experience includes various tissues and species cell models either adherent or non adherent:

  • CHO
  • Vero
  • SF9 and SF21
  • BHK21
  • HEK293
  • DF-1
  • Quail cells
  • MRC-5
  • Human lymphocytes
  • HeLa cells
  • Leukaemia cell lines

The full- list can be supplied upon demand.

Cell banking technologies

Our company offers advanced equipment and technologies to support cell banking, including static cell culture and production using flasks or multilayers for adherent cell lines, shaking cell culture using spinner or erlen flasks.

Also available is a cutting-edge wave system for suspension cell lines, as well as automatic cell counting options such as ViCell® or NucleoCounter®.

Freezing steps can be on-demand performed using a controlled rate freezer for better standardization and ensuring a better homogeneity of viability in each produced via for long term storage at low temperature.

One-stop-shop cell banking solutions:
characterization and storage of cell banks

Clean Cells is a globally recognized authority on search, technologies and techniques used for characterization of biological materials. We collaborate with worldwide companies (through every step of the process from MBC to EoPCB) to ensure the quality and safety of GMP or non-GMP biological materials.

A cell bank reaches different purposes such as stem cell-based research and development, biopharmaceutical testing and production for treating disease. 

In addition to cell banking, we offer a comprehensive range of biologics testing services that complies with regulatory requirements. 

At the end of cell banking, cell banks can be stored at Clean Cells, either as the main or the back-up storage facility.

Cell banking - one stop shop solution

Leaflet

Flyer-Prod_MCB-A4-VF

Leaflet

MCB Manufacturing Leaflet

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For more information, please do not hesitate to contact us.

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