The Montreal-based C3i Center obtained regulatory approval from the European Medicine Agency (EMA) to produce cell therapy therapies for the European market. The company obtained a certificate of GMP (Good Manufacturing Practice) compliance, enabling it to make innovative medicines available to European patients..

总部位于蒙特利尔的C3i中心获得了欧洲药品管理局 (EMA) 的监管批准，可生产用于欧洲市场的细胞治疗药物。该公司获得了GMP（良好生产规范）合规证书，能够为欧洲患者提供创新药物。

Last year, C3i became the first CDMO for cell and gene therapies in Canada to obtain a Drug Establishment License (DEL) to produce cell therapies for patients across Canada commercially.

去年，C3i 成为加拿大首家获得药物生产许可证（DEL）的细胞和基因治疗合同开发与制造组织（CDMO），可商业化生产面向加拿大患者的细胞疗法。

“As a Canadian CDMO, we’re proud to offer innovative solutions to the challenges of biomanufacturing and commercializing treatments that change lives,” said Yvan Côté, CEO. “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.

“作为加拿大的一家合同开发和生产组织（CDMO），我们很自豪能够为生物制造和商业化改变生命的治疗方案提供创新的解决方案，”首席执行官伊万·科特（Yvan Côté）表示。“我们的团队严格遵守质量和安全标准，这在我们的行业中至关重要。获得加拿大卫生部和欧洲药品管理局（EMA）的批准，再次证明了我们对患者安全和治疗产品质量的承诺。”

This level of certification makes C3i Center a Canadian reference in the field of cell therapy.”.

这一级别的认证使C3i中心成为加拿大细胞治疗领域的参考标准。

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 accredited laboratories, added Côté.

Côté补充道，内部服务包括适合开发阶段的质量控制测试、生物标志物发现、免疫监测，以及利用其美国病理学家学院认证的实验室进行的专业诊断测试。

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