Clinical-grade hES cell line derivation
With our Cellartis Clinical-Grade hES Cell Derivation Service, we generate customer-proprietary hES cell lines for use in clinical research settings. All cell-related work is performed under conditions consistent with European and US standards, at GMP manufacturing sites, by specially-trained personnel, and according to standard operating procedures. Our Cellartis Human Pluripotent Stem Cell Services team in Sweden has proven experience and delivers professional expertise through close collaboration. 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.
Derivation adheres to FDA and EU guidelines
We have a long history of work in hES cell line derivation. Between 2001 and 2004, the company established the world's largest single source of defined hES cell lines, with more than 30 ethically derived cell lines. In 2005, we established the first animal-component-free hES cell line using human feeders and human serum as a proof of principle for potential cell therapy products. Since then, we have developed a unique method to derive hES cell lines under both feeder-free and human-component-free conditions.
The starting material is sourced from a prion-free region to comply with FDA regulations. We also collaborate with IVF clinics in the US to acquire starting material sourced according to FDA and EU guidelines. Potential donors are selected in accordance with FDA and EU guidelines and under a protocol approved by local investigational review boards (IRBs).
Detailed consultation to define the project scope and requirements
Services team's oversight of the sourcing process
Thawing of the blastocysts for hES cell line derivation
Expansion of the hES cells under xeno-free, GMP conditions
Generation of Seed Banks and Master Cell Bank
QA/QC on Master Cell Bank
Transfer of the Seed Banks and Master Cell Bank to the customer
Takara Bio USA, Inc.
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