February 2025 News and Resources

CDMO News

C3i Secures EMA Approval to Manufacture Cell Therapies for Europe

C3i has obtained regulatory approval from the European Medicines Agency (EMA) to manufacture cell therapies for the European market. The certification follows an inspection of the company’s Montreal facility, which confirmed compliance with Good Manufacturing Practice (GMP) standards. This approval enables C3i, a Canadian contract development and

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CDMO News

Celonic Group Secures Multi-Year Commercial Manufacturing Deal with LINDIS Biotech

Celonic Group has entered a multi-year commercial manufacturing agreement with LINDIS Biotech to produce catumaxomab, a bispecific monoclonal antibody designed for the treatment of malignant ascites in patients with EpCAM-positive carcinomas. The agreement strengthens Celonic’s role as a CDMO in biologics contract manufacturing. Catumaxomab is a first-in-class therapy

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CDMO News

Indena Secures First-Ever European CEP Certification for CBD API

Indena has become the first active pharmaceutical ingredient (API) manufacturer worldwide to obtain a European Pharmacopoeia Certificate of Eligibility (CEP) for its cannabidiol (CBD) extract. Issued by the European Directorate for the Quality of Medicines (EDQM), the certification confirms that Indena’s

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