HAMILTON & TORONTO ONTARIO – December 23, 2026 – OmniaBio Inc., Canada’s largest cell and gene therapy (CGT) contract development and manufacturing organization (CDMO), today announced that Health Canada has awarded the company a Drug Establishment License (DEL), confirming the maturity and compliance of its Good Manufacturing Practices (GMP).
Secured less than one year after opening the Hamilton, Ontario facility, the DEL solidifies OmniaBio’s position as a leading CGT manufacturer and marks an extraordinary achievement by the OmniaBio’s team.
“Receiving the DEL in such a short timeframe is a testament to the expertise, commitment, and relentless drive of both our people and the power of the Canadian biotechnology ecosystem,” said Michael May, Interim CEO of OmniaBio.
The DEL is Health Canada’s formal certification that authorizes a facility to conduct regulated GMP activities. The approval process consisted of a comprehensive audit of the quality systems that support GMP compliance across the organization. This ensures regulatory compliance and enables the consistent release of high-quality products to clinics and markets.
“From qualification and validation through batch release, our teams have built a robust, scalable, and compliant manufacturing platform,” said Kevin Scannell, Vice President of Quality Assurance & Regulatory Compliance. “Health Canada’s DEL reflects our team’s commitment to manufacturing the highest quality products while maintaining critical timelines for our clients and their patients.”
About OmniaBio Inc.
OmniaBio manufactures advanced cell and gene therapies, including CAR-T therapies, induced pluripotent stem cell (iPSC)-derived products, lentiviral vectors (LVV), and other cell-based therapies, supporting clients from early clinical development through commercial-scale production. The company is also developing advanced automation, robotics, and digital systems through its vision for The Intelligent Factory™ to bring scale to autologous CAR-T therapy manufacturing.
Learn more at omniabio.com.
Media Contact:
Dan Salvo
Vice President, Marketing & Creative
Daniel.Salvo@omniabio.com