C3i Center Inc is First CDMO in Canada to Receive Approval for a Drug Establishment License to Commercially Produce Cell Therapy Drug Products
C3i Center Inc (C3i) announced it has received regulatory approval, in the form of a Drug Establishment License (DEL), to commercially produce cell therapies, making C3i the first CDMO in Canada to achieve this milestone.
The approval follows an inspection by the cell and gene therapy experts from Health Canada. The DEL approval recognizes C3i as having industry-leading expertise, regulatory know-how, and strong quality standards.
“The C3i team worked hard to meet the requirements of a DEL and are proud that we received approval from Health Canada to commercially manufacture cell therapies.” – Louisa Petropoulos, CEO of C3i. “We are excited to be the first CDMO in Canada to reach this milestone, and there is more to come. Our goal is to manufacture cell and gene therapies for the global market. We expect to have the European Medicines Agency (EMA) conduct their inspection later this fall.”
C3i supports its clients in process development, scale-up and manufacturing for phase 1 to phase 3 clinical trials, as well as commercial cell and gene-modified cell therapies. C3i continues to expand its capabilities to include the production of viral vectors, exosomes, and other autologous and allogeneic cellular therapies.
About C3i Center Inc
C3i is a full-service, in-house CDMO with a vision to make life-saving cell and gene therapies available to everyone who needs them. C3i provides services to biotechnology companies, academic research groups, and pharmaceutical companies, supporting the advancement and commercialization of innovative technologies. C3i’s dedicated team is focused on providing clients with tailored services to meet their specific needs, expediting their innovative pipeline from development to commercial. C3i prides itself on delivering on-time, cost-efficient quality results. In-house services include phase-appropriate quality control testing, biomarker discovery, immune monitoring and diagnostic testing with College of American Pathologists (CAP)-accredited laboratories.
To learn more about who we are, visit www.c3icenter.com and for business inquiries, please contact our VP of Business Development, Sandra Donaldson, at sdonaldson@centrec3i.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240620081082/en/
Contacts
sdonaldson@centrec3i.com
(c) 2024 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
KIOXIA and Linus Media Group Set World Record for Pi Calculation19.5.2025 08:00:00 CEST | Press Release
Kioxia Corporation, a world leader in memory solutions, today announced that it has collaborated with Linus Media Group, creator of Linus Tech Tips and other influential technology-focused YouTubeTM channels, to set a new GUINNESS WORLD RECORDS® title for the Most Accurate Value of Pi. A groundbreaking 300 trillion digits were calculated and have been officially verified and confirmed by Guinness World Records1. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250518801709/en/ KIOXIA SSD The record-smashing computation was enabled by a high-performance storage cluster comprising 2.2 petabytes (PB)2 of 30.72 terabyte (TB) CM Series and 15.36 TB CD Series PCIe® NVMe™-based solid-state drives (SSDs) from KIOXIA. These SSDs were configured in a network-attached storage environment connected to a dual-CPU compute server and ran for nearly seven and a half months. Pi (π) represents the mathematical constant expressing the ratio of a
NetApp Builds AI Infrastructure on NVIDIA AI Data Platform19.5.2025 08:00:00 CEST | Press Release
NetApp® (NASDAQ: NTAP), the intelligent data infrastructure company, today announced that it is working with NVIDIA to support the NVIDIA AI Data Platform reference design in the NetApp AIPod solution to accelerate enterprise adoption of agentic AI. Powered by the robust and mature data management capabilities of NetApp ONTAP®, NetApp AIPod deployments built on the NVIDIA AI Data Platform will help businesses build secure, governed, and scalable AI data pipelines for retrieval-augmented generation (RAG) and inferencing, enabling organizations to harness the full potential of AI innovation. As businesses invest in AI to solve complex business challenges, they need intelligent data infrastructure that can remove the data silos that slow technical innovation. The most recent NetApp Data Complexity report found that 79 percent of tech and business leaders agree that unifying their data estates is critical for achieving top AI outcomes in 2025. As a NVIDIA-Certified Storage partner leveragi
Fujirebio Receives Marketing Clearance for Lumipulse ® G pTau 217/ β-Amyloid 1-42 Plasma Ratio In-vitro Diagnostic Test as an Aid to Identify Patients With Amyloid Pathology Associated With Alzheimer’s Disease17.5.2025 08:58:00 CEST | Press Release
Fujirebio today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test for the assessment of amyloid pathology in patients being evaluated for Alzheimer’s disease and other causes of cognitive decline. The test, which was granted Breakthrough Device Designation by the FDA, is the first FDA cleared blood-based IVD test in the U.S. to aid to identify patients with amyloid pathology associated with Alzheimer’s Disease (AD). Alzheimer’s disease currently affects an estimated 7.2 million Americans, a number projected to rise to nearly 14 million by 2060.1 It is a leading cause of disability and death. AD develops over many years, long before symptoms are evident, but the lack of accessible, minimally invasive diagnostics results in many patients remaining undiagnosed until the disease is well advanced, when few effective interventions remain. The Lumipulse G pT
IFF Announces Pricing of Tender Offers For Certain Outstanding Series of Notes16.5.2025 23:17:00 CEST | Press Release
IFF (NYSE: IFF) announced today the Total Consideration (as defined below) payable in connection with its previously announced tender offers to purchase for cash: (i) up to $1,100,000,000 aggregate purchase price, excluding accrued and unpaid interest (the “Amended Pool 1 Maximum Amount”), of its 1.230% Senior Notes due 2025 (the “2025 Notes”), 1.832% Senior Notes due 2027 (the “2027 Notes”), 4.450% Senior Notes due 2028 (the “2028 Notes”) and 2.300% Senior Notes due 2030 (the “2030 Notes” and collectively with the 2025 Notes, the 2027 Notes and the 2028 Notes, the “Pool 1 Notes”) and (ii) up to $900,000,000 aggregate purchase price, excluding accrued and unpaid interest (the “Amended Pool 2 Maximum Amount” and, together with the Amended Pool 1 Maximum Amount, the “Amended Maximum Amounts”), of its 3.268% Senior Notes due 2040 (the “2040 Notes”), 4.375% Senior Notes due 2047 (the “2047 Notes”), 5.000% Senior Notes due 2048 (the “2048 Notes”) and 3.468% Senior Notes due 2050 (the “2050
Origins Launches in the U.S. Amazon Premium Beauty Store16.5.2025 15:00:00 CEST | Press Release
Origins, with over 30 years of expertise in combining naturally-derived and scientifically crafted ingredients for powerful skincare, announced its official debut in the U.S. Amazon Premium Beauty store today. Origins will offer its iconic skincare and body care products along with giftable sets that are perfect for any occasion. Origins will now bring naturally-derived, effective beauty to Amazon customers nationwide with convenience and thoughtful gifting in mind. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250516435958/en/ This launch marks a strategic step in Origins’ ongoing efforts to meet the evolving needs of skincare shoppers, seeking high-performance, conscious beauty on their favorite platforms. By expanding to the U.S. Amazon Premium Beauty store, Origins reinforces its commitment to delivering both efficacy and accessibility to even more consumers. Amazon customers will now be able to discover and purchase Or
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom