C3i Center receives approval from the EMA to manufacture cell therapy products for the European market.

C3i announces that it has obtained regulatory approval from the EMA (European Medicine Agency) to produce cell therapy treatments for the European market.

The company received a certificate of Good Manufacturing Practice (GMP) compliance following an inspection of their Montreal facility by the European Medicines Agency.

Therefore, C3i 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 commercially for patients across Canada. 

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.”

For more details, read the full press release here.