Cell Lines and Fields of Use

1.

Q: What cell types are available for commercial licensing?

Answer

A: Both CHO-S® Cells (cGMP banked) and CHO DG44 Cells (cGMP banked) can be licensed for commercial applications.

2.

Q: What fields of use are allowed?

Answer

A: 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.

3.

Q: Is there information on these cell lines to support regulatory filings?

Answer

A: 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 Life Technologies through delivery to the purchaser, as well as all testing reports.

General Licensing Terms

4.

Q:  When is a license required for CHO-S® cells or DG44 cells?

Answer

A: 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:

  1. 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.
  2. A Commercial Service Provider License is required by service providers prior to use of cells for any client projects.
5.

Q: Are separate licenses required for CHO-S® cells and DG44 cells?

Answer

A: Yes. Each cell line requires a separate Commercial Production or Service License.

6.

Q: Is there a pull-through royalty on final products or an annual maintenance fee?

Answer

A: 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.

7.

Q: What is the term of the license agreement for CHO-S® cells and DG44 cells?

Answer

A: Licensing rights are granted in perpetuity for the Commercial Production License.  The term of the Commercial Service License is negotiated between the parties.

8.

Q: How Can I learn more about commercial licensing of Freedom® kits, CHO-S® and CHO DG44 cell lines?

Answer

A: To inquire about a Commercial Production or Service License, please email:
outlicensing@lifetech.com