STEMCELL Technologies and the Centre for Commercialization of Regenerative Medicine (CCRM) today announced a partnership to expand access to high-quality human induced pluripotent stem cell (iPSC) starting materials, giving cell therapy developers worldwide a faster, lower-risk path from research to the clinic. Under the agreement, STEMCELL will manufacture and distribute research-use-only (RUO) iPSC lines derived directly from LineaBio's Good Manufacturing Practices (GMP) iPSC lines, and will offer the matched GMP lines to developers worldwide.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708212795/en/
Partnership pairs GMP-manufactured iPSC lines with matched RUO equivalents, giving developers well-characterized, donor-eligible starting materials from early research through clinical development. Supporting comparability data for the RUO and GMP lines to be presented at the 2026 ISSCR Annual Meeting in Montréal, Canada.
For developers of iPSC-derived cell therapies, the starting cell line is a foundational choice that shapes the entire path to the clinic. A 2026 review in Stem Cell Reports identified 126 human iPSC lines available for clinical applications, but few offer the full set of attributes that reduce development risk: donor consent for commercial and therapeutic use, cleanroom-based GMP manufacturing, comprehensive genomic characterization, and clear freedom to operate. A shortfall in any of these may not surface until late in development, when a change of starting material can trigger a new regulatory filing, adding significant time and cost.
"As a company of Scientists Helping Scientists, STEMCELL is committed to providing cell therapy developers with iPSC starting materials they can rely on as they move from research toward the clinic," said Dr. Allen Eaves, President and CEO, STEMCELL. "By offering LineaBio's GMP iPSC lines alongside matched RUO lines manufactured from the same material, we are giving scientists a dependable foundation for their work and helping to accelerate the development of new cell therapies."
"LineaBio was founded to give cell therapy developers off-the-shelf GMP iPSC lines backed by the documentation, characterization, and regulatory support they need," said Dr. Michael May, President and CEO, CCRM. "Working with STEMCELL and its reach into research laboratories worldwide, we can expand access to these lines across the research community and help accelerate the next generation of cell therapies for patients. We are proud to advance this work with a fellow Canadian company, expanding access to these tools for scientists worldwide."
LineaBio's iPSC lines are manufactured under controlled GMP conditions from donor-eligible source material and characterized extensively, including by whole genome sequencing. The flagship line, Linea 1, is certified by the Human Pluripotent Stem Cell Registry (hPSCreg®) and supported by a U.S. FDA drug master file, giving developers a standardized chemistry, manufacturing, and controls (CMC) data package they can reference in their own regulatory submissions to shorten their path to GMP and reduce cell line development costs. STEMCELL generates matched RUO counterparts directly from this GMP material and qualifies them using established comparability and genomic assessment frameworks. Because the RUO and GMP lines share the same donor and origin, developers can begin their research on the RUO line with confidence that it is comparable to the GMP material. The partnership will expand to include future GMP iPSC lines, including a hypoimmune line for allogeneic therapies.
The companies will present comparability and genomic concordance data for Linea 1 during the STEMCELL and CCRM Innovation Showcase at the 2026 International Society for Stem Cell Research (ISSCR) Annual Meeting in Montréal, "Accelerating Cell Therapy Development with GMP-Manufactured Human iPSC Lines and Matched RUO Equivalents," presented by Dr. Andrew Gaffney (STEMCELL) and Dr. Janet Rothberg (CCRM) on Wednesday, July 8, at 12:30 p.m. ET in Room 511a, Palais des congrès de Montréal. To learn more about the iPSC lines, visit www.stemcell.com/gmp-ipscs.
About STEMCELL Technologies
STEMCELL Technologies supports life sciences research with more than 2,500 specialized reagents, tools, and services. STEMCELL offers high-quality cell culture media, cell separation technologies, instruments, accessory products, educational resources, and contract assay services that are used by scientists performing stem cell, immunology, cancer, regenerative medicine, and cellular therapy research globally. As referred to here, “STEMCELL” includes STEMCELL Technologies and the STEMCELL Group of Companies. Visit us at stemcell.com.
About CCRM
CCRM is a global, public-private partnership headquartered in Canada. It has received funding from the Government of Canada, the Province of Ontario, and leading academic and industry partners. CCRM supports the development of regenerative medicines and associated enabling technologies, with a specific focus on cell and gene therapy. A network of researchers, leading companies, investors, and entrepreneurs, CCRM accelerates the translation of scientific discovery into new companies and revolutionary medicines for patients with specialized teams, dedicated funding, and unique infrastructure. In 2022, CCRM established OmniaBio Inc., a commercial-stage CDMO for manufacturing cell and gene therapies. Visit us at ccrm.ca.
About LineaBio
LineaBio's mission is to enable the cell and gene therapy industry by providing access to high-quality, off-the-shelf iPSC lines manufactured under GMP that streamline drug product manufacturing. By allowing therapeutic developers to cut costs and accelerate timelines for GMP reprogramming, LineaBio strives to achieve its vision of making cell therapy universally accessible and affordable. Founded in 2023 by parent companies CCRM and OmniaBio, LineaBio draws on a team of iPSC experts that have been developing an iPSC platform since 2012. Visit www.lineabio.com to learn more.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260708212795/en/
© Business Wire, Inc.
Aviso legal :
Este comunicado de imprensa não é um documento produzido pela AFP. A AFP não será responsável por este conteúdo. Para mais informações, por favor entre em contato com as pessoas ou entidades mencionadas no comunicado.