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.
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
Detailed consultation to define the project scope and requirements

Services team's oversight of the sourcing process
Thawing of the blastocysts for GMP-grade hES cell line establishment
Expansion of the hES cells under xeno-free, GMP-grade conditions
Generation of Seed Banks
Generation of a Master Cell Bank

Transfer of the Seed Banks and Master Cell Bank to the customer
Project initiation
- Submit the service inquiry form to the left.
- We contact you to go over your project requirements and provide a quote.
- We perform the agreed-upon service according to the designated lead times.
- 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
Takara Bio USA, Inc.
United States/Canada: +1.800.662.2566 • Asia Pacific: +1.650.919.7300 • Europe: +33.(0)1.3904.6880 • Japan: +81.(0)77.565.6999
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