CCRM and OmniaBio spin-off provides high-quality iPSC lines that expedite time to GMP by 12 months and reduce cell line development costs by up to 60%
July 30, 2024 (Toronto, Ontario) – LineaBio, a cell line company, today announced the launch of its catalogue of off-the-shelf induced pluripotent stem cell (iPSC) lines. The off-the-shelf iPSC lines, manufactured in compliance with Good Manufacturing Practices (GMP), will enable cell therapy developers by accelerating time to GMP by 12 months and reducing cell line development costs by up to 60 per cent.
“What differentiates LineaBio’s cell line catalogue is quality and transparency,” says Mark Curtis, CEO of LineaBio. “Leveraging an established platform and team of iPSC experts, our iPSC lines are manufactured in compliance with GMP from start to finish, without compromise. By providing industry access to off-the-shelf iPSC lines of this calibre for drug product manufacturing, LineaBio’s cell line catalogue will help therapeutic developers cut costs and expedite timelines for GMP reprogramming—ultimately increasing the likelihood of more cell therapy drug products making their way into the clinic to help patients in need.”
LineaBio was founded by parent companies CCRM, a global leader in iPSC capabilities and platform development, and OmniaBio, a technology-focused cell and gene therapy clinical and commercial contract development and manufacturing organization (CDMO). LineaBio’s proprietary GMP iPSC lines are based on more than a decade of iPSC platform expertise honed at CCRM, including reprogramming 200+ iPSC lines, a number of which were manufactured in compliance with GMP for customer Investigational New Drug (IND)-enabling studies. Additionally, the affiliation with OmniaBio provides developers with a seamless path to the manufacturing of master and working cell banks, process and analytical development, and ultimately clinical and commercial GMP drug products.
LineaBio’s iPSC lines are manufactured using a platform that includes reprogramming, clonal selection, and banking, performed in compliance with GMP, using GMP reagents with full traceability. LineaBio will launch its first proprietary GMP iPSC line in August, which will be supported by a U.S. FDA drug master file that will be submitted this year.
LineaBio CEO Curtis has spent the last 15 years in the cell and gene therapy industry, working in manufacturing and drug development. Prior to joining LineaBio, he was a CMC lead for the Fabry, Pompe and Gaucher programs at AVROBIO, an ex vivo gene therapy company focused on rare disease. Before AVROBIO, Curtis spent several years in the cell and gene technologies business unit at Lonza, a global CDMO, in roles spanning strategy, acquisitions and business development.
To learn more about LineaBio’s unique catalogue, visit www.lineabio.com.
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.
For further information, please contact:
Stacey Johnson
Vice President, Communications and Marketing
CCRM and OmniaBio Inc.
stacey.johnson@ccrm.ca