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GMP-Creative Biolabs, One-stop, Full cGMP Service, Fasten Your Process to Cinical and Market

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USA
45-1 Ramsey Road, Shirley, NY 11967, USA
Tel: 1-631-871-5806
Fax: 1-631-207-8356
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Cell Expansion, Harvest & Cryopreservation

Cell Expansion, Harvet & Cryopreservation

Creative Biolabs provides cGMP cell banking service to suit client’s demands for large scale cGMP industry manufacture. Establishing a cGMP cell bank(MCB and WCB) is the first critical step for biopharmaceutical production, which can minimize the potential risk factors of maintaining a cell line, such as microbial contamination, loss of characteristics of interest, genetic drift and so on. At Creative Biolabs, cell banking can be manufactured with different batch sizes by using multiple expansion methods including T-flasks, cell factories, roller bottles, shake flasks and spin flasks. Cell banking service is available for cells of various species at Creative Biolabs.

Standard Procedure for cGMP Cell Banking:

1) Seed stock material test for sterility and adventitious agents like mycoplasma or bacteriophage

2) Purchase of raw material for cGMP cell banking from QA-approved vendors

3) Manufacture of MCB and WCB on a campaign basis with validated cleaning and change-over procedures

4) Quality controls tightly engaged during the whole process

5) Testing services available for cell count and viability, microbial QC, recovery viability and growth after cryopreservation

6) Qualified MCB and WCB, with cell concentration and number of cryogenic vials at customer’s request

7) Storage in highly monitored cGMP Nitrogen tanks until release


Flow Chart of Creative Biolabs Cell Banking


Cell Banking Flow chart

To discuss your Cell Expansion, Harvest & Cryopreservation demands or to request a proposal, please contact us by