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  • Clinical-grade hES cell line derivation
Takara Bio granted manufacturing license for clinical-grade hES cell line derivation
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Takara Bio granted manufacturing license for clinical-grade hES cell line derivation
Differentiating cells Expert advice: hESC-based cell therapy development
GMP-grade culture medium Featured product: GMP-grade culture medium

Contact us about stem cell services

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Cellartis human pluripotent stem cell services

Clinical-grade hES cell line derivation

Generating robust human embryonic stem cell lines under GMP-grade conditions is critical for the progression of clinical research using ES cells. To help you obtain the highest-quality custom cell line, we will work together to define the exact specifications for your cells, and then we will take care of sourcing and derivation under stringent ethical and safety conditions.

If you don’t need a custom line, you can license one of our nonexclusive clinical-grade hES cell lines. Whichever service you pick, you can expect a close, worry-free collaboration with straightforward and prompt communication about requirements, timelines, and deliverables.

For more information, please submit an inquiry using the form on the left. If you are on a mobile device, click on the hamburger icon () on the top left of your screen, then scroll down to access the form.

Overview Derivation process Project initiation Out-licensing program

Overview  

With the Cellartis Clinical Grade hES Cell Derivation Service, we will deliver clinical-grade human ES cell lines for use in clinical research settings. The proprietary hES cell establishment method is feeder-free and xeno-free. The starting material is retrieved from FDA-compliant sources according to FDA guidelines. In 2018, our specialized facility in Gothenburg, Sweden was granted a manufacturing license by the Medical Products Agency (the Swedish national authority) for clinical-grade human embryonic stem cell line derivation and banking.

Our derivation package to create hES cell lines from sourced blastocysts starts with a detailed consultation to determine exact project requirements, desired QC tests to be performed on the Seed Banks and Master Cell Bank, deliverables, and timelines. The services team will use those specifications to oversee the sourcing process, including IRB/ethical approval, donor consent, donor screening (medical history interview, physical examination, and testing for infectious diseases), and transfer of blastocysts to the services team. Under GMP-grade conditions, the blastocysts will be thawed, the hES cell line will be created, and the cells expanded in our Cellartis DEF-CS 500 Xeno-Free GMP Grade Basal Medium. The final cell materials will be banked and characterized, then delivered to you.

Derivation process  


Detailed consultation to define the project scope and requirements
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Services team's oversight of the sourcing process
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Thawing of the blastocysts for GMP-grade hES cell line establishment
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Expansion of the hES cells under xeno-free, GMP-grade conditions
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Generation of Seed Banks
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Generation of a Master Cell Bank
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Transfer of the Seed Banks and Master Cell Bank to the customer

Project initiation  

  1. Submit the service inquiry form to the left.
  2. We contact you to go over your project requirements and provide a quote.
  3. We perform the agreed-upon service according to the designated lead times.
  4. We provide you with the agreed-upon deliverables.

Out-licensing program  

To provide you with faster access to clinical-grade starting material, we have established a licensing program that allows the use of Takara Bio’s nonproprietary clinical-grade hES cells for commercial cell therapy products. As with our derivation service, our clinical-grade lines were derived and expanded under feeder-free and xeno-free culture conditions in our state-of-the-art GMP facility. Starting material was sourced from prion-free countries, from donors who were tested within seven days of retrieval according to the FDA’s requirements. To learn more, please submit the inquiry form to the left.

Clinical-grade hES cell line derivation services

Cat. # Product Size License Quantity Details
Y60155 Cellartis® Clinical Grade hES Cell Derivation Service Each Inquire for Quotation

License Statement

ID Number  
C011 This service is performed by Takara Bio Europe AB based on a commercial license to certain intellectual property rights held by Wisconsin Alumni Research Foundation (“WARF”). The deliverables and their use are covered by one or more claims of U.S. Patent No. 7,514,260 and its foreign counterparts. The purchase of this service conveys to the buyer the non-transferable right to use the deliverables for their intended use, strictly limited to purchaser’s own internal research. No other express or implied license is granted to the purchaser. Purchaser cannot have any right to use the deliverables or its components in humans for any purposes including but not limited to diagnostics and/or therapeutics, or otherwise clinical trials. Purchase does not include any right to resell or transfer the deliverables to a third party regardless of whether or not compensation is received. Purchasers wishing to use the deliverables for purposes other than internal research use should contact us.
*

With Cellartis clinical-grade hES cell line derivation services, we will deliver clinical-grade human ES cell lines for use in clinical research settings.

Notice to purchaser

Our products are to be used for Research Use Only. They may not be used for any other purpose, including, but not limited to, use in humans, therapeutic or diagnostic use, or commercial use of any kind. Our products may not be transferred to third parties, resold, modified for resale, or used to manufacture commercial products or to provide a service to third parties without our prior written approval.

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