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View additional product information for ExpiCHO-S™ Cells (cGMP Banked) - FAQs (A37785)
31 product FAQs found
After execution and payment for a Commercial Production License, a Cell Line Documentation Package (>200 pages, and specific to the lot of cells purchased), is provided, which includes the entire lineage history of the cells, starting at receipt of the initial vial at Thermo Fisher Scientific through delivery to the purchaser, as well as, all testing reports.
Find additional tips, troubleshooting help, and resources within our Protein Expression Support Center.
Yes. Contact our Field Application Scientists for technical support.
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Please contact our licensing team at outlicensing@thermofisher.com to obtain details.
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No. There is a one-time license fee required prior to IND and an additional fee at the time of commercialization.
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A commercial use license is required prior to the sale of expressed proteins, or when an IND submission is being prepared for human clinical studies.
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Only two transfections are recommended.
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FreeStyle MAX Reagent is included in the Freedom ExpiCHO-S Kit as the preferred transfection reagent. ExpiCHO-S Cells (cGMP banked) are also compatible with the Neon Transfection System (optimization of instrument settings is required).
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Limiting dilution cloning is recommended with the Freedom ExpiCHO-S Kit.
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Puromycin in combination with methotrexate (MTX) is used to select for stable pools following transfection with the Freedom pCHOm 3.1 and Freedom pCHOp 3.2 vectors.
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The Freedom ExpiCHO-S two vector system provides the ability to control the ratio of heavy to light chains while allowing for consistent genomic background for transient and stable workflows.
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A certificate of analysis (COA) demonstrating suitability for research use is available to everyone who purchases the Freedom ExpiCHO-S Kit or the ExpiCHO-S Cells (cGMP banked). A full documentation package, including the cell line's lineage, history, and cGMP testing results, is offered upon execution of a commercial use license.
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The Freedom ExpiCHO-S Kit contains all major components needed for the development of stable clones, including ExpiCHO-S Cells (cGMP banked), vectors, and media. A complete list of components, including additional materials required but not included, can be found in the ExpiCHO Expression System Kit manual (https://www.thermofisher.com/document-connect/document-connect.html?url=https%3A%2F%2Fassets.thermofisher.com%2FTFS-Assets%2FLSG%2Fmanuals%2FMAN0025765_FreedomExpiCHO-S_Kit_UG.pdf).
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Yes. ExpiCHO-S Cells (cGMP banked) are intended (with the purchase of a commercial license) for the development of biologics. They have been produced in a cGMP animal origin-free environment and have been scaled up in a commercial setting to produce products for clinical testing.
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ExpiCHO-S clones producing a model IgG protein were assessed for stability by comparing volumetric productivity for over 60 generations. Four out of the five clones that were tested maintained expression levels over 60 generations. Expression levels were considered stable if the titer at the end of the stability assessment (at generation 60) was at least 70% of the titer observed at the beginning of the stability study.
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It is possible to go from transfection to lead clone in as little as 4 months with the Freedom ExpiCHO-S Kit.
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Volumetric titers of over 3 g/L in fed batch have been obtained with the Freedom ExpiCHO-S Kit.
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To inquire about a Commercial Production or Service License, please email: outlicensing@thermofisher.com.
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Licensing rights are granted in perpetuity for the Commercial Production License. The term of the Commercial Service License is negotiated between the parties.
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Only a one-time license fee is required for a Commercial Production License, and it covers use during the clinical trial process and commercialization of an unlimited number of molecules.
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Yes. Each cell line requires a separate Commercial Production or Service License.
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A Limited Use Label License, which includes research rights, is available in the product manual and applies when the cells are purchased. An additional Commercial Production or Service License is required in the following circumstances:
- A Commercial Production License is required prior to the clinical use in humans of expressed proteins, and/or when an IND submission is being prepared for first in human clinical studies.
- A Commercial Service Provider License is required by service providers prior to use of cells for any client projects.
Find additional tips, troubleshooting help, and resources within our Protein Expression Support Center.
Yes. After execution and payment for a Commercial Production License, a Cell Line Documentation Package (>200 pages, and specific to the lot of cells purchased), is provided which includes the entire lineage history of the cells starting at receipt of the initial vial at Thermo Fisher Scientific through delivery to the purchaser, as well as all testing reports.
Find additional tips, troubleshooting help, and resources within our Protein Expression Support Center.
Many fields of use are available, including development and production of molecules in the area of human biotherapeutics, human vaccines, veterinary vaccines, human diagnostics, or animal diagnostics, and production of proteins for sale into research markets. For more details about fields of use, please contact us at outlicensing@thermofisher.com.
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ExpiCHO-S Cells (cGMP banked), CHO-S Cells (cGMP banked), and CHO DG44 Cells (cGMP banked) can be licensed for commercial applications.
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Before transfecting ExpiCHO cells, there is no need to change out the media during the subculturing. This would become expensive and the conditioned media is not necessary.
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For optimal performance with respect to protein production, we recommend thawing ExpiCHO cells and letting them grow for 2-3 passages prior to transfection. Overall, we do not recommend using the cells beyond ˜20 passages.
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To inquire about a Commercial Production or Service License, please send an email to outlicensing@thermofisher.com
As long as the license is not in breach, commercial use rights are granted in to perpetuity for the Commercial Production of the Commercial License. The term of the Service License is negotiated between the parties.
Only a one-time license fee is required for a Commercial Production License, and it covers use during the clinical trial process and continues through the commercialization of one molecule.
A license is required under the following circumstances:
- A Commercial Production License is required prior to the clinical use in humans, of expressed proteins, and/or when an IND submission is being prepared for first-in-human clinical studies.
- A Commercial Service Provider License is required by service providers (e.g. CMOs, CROs, etc.) prior to use of cells for any client projects, regardless of client end-use.
A Limited Use Label License (“LULL”) accompanies each purchase of cGMP-banked ExpiCHO-S Cells (“Cell Line”) from Life Technologies Corporation (“LIFE”) by the LIFE customer (“Customer”). The rights granted to a Customer with the purchase of such Cell Line from our catalog in the LULL include the following:
- Internal research use by Customer of such purchased Cell Line and the resulting molecules produced by such Cell Line.
- Transfer of such Cell Line by Customer to a service provider (e.g., contract manufacturing organization (“CMO”) or contract research organization (“CRO”)) for Cell Line development and/or protein production solely for research and solely on behalf of and for the benefit of the Customer who purchased such Cell Line.