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GeniBet Biopharmaceuticals

The team: Teresa Alves, Raquel Fortunata, Somesh Sharma & António Cunha

Expertise: GenIbet  is a biopharmaceutical CMO (Contract Manufacturing Organization) offering highly specialized microbial and cell culture process development and cGMP manufacturing services to research groups, biotech and pharma companies. GenIbet’s core activity is the manufacture and supply of materials for use in early stage drug development, pre-clinical studies and cGMP manufacturing for Phase I and II clinical trials. It has extensive expertise in molecular biology, virology, bacterial and cell culture of its partner and main shareholder, IBET (Instituto de Biologia Experimental e Tecnológica).

Role in the project: Genibet will work with P2 and P4 to help establish two cGMP Master Cell Bank (MCB), one for each cell lines expressing the target monoclonal antibodies, and perform the associated Quality and In-Process Control analysis. They will aids the transfer to the cGMP facility and be responsible for production of one clinical lot of each target monoclonal antibody and perform the associated Quality and In-Process Control analysis according to the cGMP requirements.

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