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.

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

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.

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.