Expert advice on hESC-based cell therapy development

Human embryonic stem (hES) cells have tremendous potential for treating humanity's currently incurable diseases and injuries. Differentiated cells produced from hES cells are being explored for their potential to treat a long list of ailments, including diabetes and age-related macular degeneration. It's going to take a combination of excellent tools and strong partnerships to further advance our understanding of these diseases and translate those learnings into new therapies.

Developing an hES cell-based therapy is a significant undertaking. It requires careful consideration of several factors, such as ethically obtaining high-quality, GMP-grade hES cells; scaling up the cell product to clinically relevant quantities; and following regional requirements and regulations. It also requires an understanding of the current and future hES cell therapy landscapes.

To illuminate some of the most important aspects that maximize the success of cell therapy development, we asked our experts to share their insights and best practices. Read on for their top 5 tips.

Utilize a trusted sourcing partner to obtain quality starting material

The quality of your finished product is reliant on the quality of your starting material. Working with a reliable sourcing partner will help you define the exact specifications for your cells and provide you with consistently high-quality starting material by taking care of sourcing and derivation under stringent ethical and safety conditions.

Ensure personnel are highly trained and have experience in deriving clinical grade lines

Working with Takara Bio provides access to a dedicated team of technical experts, all of whom have hands-on experience in basic and applied sciences and many of whom have been with Takara Bio since the beginning. From the initial consultation to the comprehensive donor screening process, they will prepare you to product the highest quality finished product once the starting cell lines have been banked, characterized, and handled into your care.

Define your cells early to ensure predictable and reliable production

Defining clear and exacting specifications for your cells early on will ensure high cell quality, from the starting material to the finished product. The Takara Bio derivation process to create hES cell lines from sourced blastocysts starts with a detailed consultation to determine exact project requirements, desired quality control 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. Under GMP-grade conditions, the blastocysts will be thawed, the hES cell line will be created, and 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.

Use a GMP manufacturing facility with appropriate licensing, that is compliant with EUR and US regulations

As we are compliant with regulatory standards around the world and can assist with navigating regulations, your cell or gene therapy will have the best possible start to reach patients around the world. The proprietary hES cell establishment method is feeder-free and animal/human component-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 rigorous and comprehensive quality control system has been designed in collaboration with Kyoto University's Center for iPS Cell Research and Application (CiRA), headed by Shinya Yamanaka.

Consider your ability to expand to scale early in the commercialization process

With the Cellartis Clinical Grade hES Cell Derivation Service, Takara Bio will deliver clinical-grade human ES cell lines for use in clinical research settings. Our long history of quality is now paired with GMP compliance, bringing an added level of confidence and consistency to our product and service portfolio. Our GMP-grade products and the deliverables of your custom projects are manufactured under rigorous standards to ensure quality and consistency, in facilities compliant with GMP regulations and guidelines.

Would you like to learn more about the future landscape of embryonic stem cell research and cell-based therapies? Take a listen to an interview with our experts:

Takara Bio offers high-quality, innovative tools and stem cell services to help research groups accelerate translational and clinical discoveries. As a contract manufacturing organization (CMO), we offer comprehensive and seamless manufacturing and quality-testing services for cell and gene therapy products. We build trustworthy, long-term relationships with our customers and have a successful track record of creating products and processes used in a variety of life science research and clinical applications. Our experienced, dedicated team of scientists and business professionals will partner with you to provide customized solutions for your specific requirements. We look forward to working with you every step of the way, from initial consultation to final product delivery.

To inquire about clinical-grade hES cell derivation and other stem cell services, please fill out the form on the left. If you are on a mobile device, click on the hamburger icon () on the top left of your screen, and then scroll down to access the form.