The company received a certificate of Good Manufacturing Practice (GMP) compliance following an inspection of their Montreal facility by the European Medicines Agency
MONTRÉAL, Feb. 19, 2025 (GLOBE NEWSWIRE) -- C3i Center (C3i) announces that it has obtained regulatory approval from the EMA (European Medicine Agency) to produce cell therapy treatments for the European market. C3i, therefore, obtains a certificate of GMP (Good Manufacturing Practice) compliance, enabling it to make innovative medicines available to European patients.
Last year, C3i became the first contract development and manufacturing organization (CDMO) for cell and gene therapies in Canada to obtain a Drug Establishment License (DEL) to produce life-saving cell therapies for patients across Canada commercially. With authorization from the European Medicines Agency (EMA) to manufacture cell therapies for the European market, C3i positions itself on the global biotechnology stage as Canada's pre-eminent cell and gene therapy CDMO. These approvals demonstrate the expertise of C3i and its multidisciplinary team, regulatory know-how, and high-quality standards.
Here is a quote from Yvan Côté, CEO of C3i:
"As a Canadian CDMO, we're proud to offer innovative solutions to the challenges of biomanufacturing and commercializing treatments that change lives. Our team adheres to strict quality and safety standards, which are crucial in our industry. Obtaining approvals from Health Canada and the EMA reaffirms our dedication to patient safety and the quality of therapeutic products. This level of certification makes C3i Center a Canadian reference in the field of cell therapy."
About C3i Center
C3i is a full-service CDMO dedicated to making life-saving cell and gene therapies available to all who need them. C3i provides services to hospitals, academic researchers, biotech and pharmaceutical companies, supporting the advancement and commercialization of innovative technologies. C3i's dedicated team ensures that customers receive services tailored to their specific needs, accelerating the transition of their innovative project from development to commercialization. In-house services include quality control testing appropriate to the development phase, biomarker discovery, immune monitoring and specialized diagnostic testing using its College of American Pathologists (CAP) accredited laboratories.
To learn more about who we are, visit www.c3icenter.com. For business inquiries, please contact by email our Associate Director of Business Development, Jamie Sharp, or by phone at 514-400-4866.
