GenIbet Biopharmaceuticals

GenIbet Biopharmaceuticals

A CGMP bridge to personalized medicine

GenIbet Biopharmaceuticals is a Contract Development Manufacturing Organization (CDMO) offering highly specialized services for the development and production of biologics in accordance with Pharmaceutical Industry Good Manufacturing Practices (GMP). Created in 2006, GenIbet is a pioneer in its field, and the first Portuguese company to obtain a manufacturing authorization for experimental drugs, recognized by the European Medicines Agency.

GenIbet’s core business is the manufacture of biological drugs for Clinical Trials and has extensive experience in Bioprocess Development and the development, qualification and implementation of analytical methods. Specifically, GenIbet has been a partner in the manufacture of varied vaccines, including an mRNA vaccine for Modern; Malaria vaccines, recombinant proteins using different expression systems, oncolytic viruses, and microbiome therapeutics.

Thanks to its in-house end-product filling capacity, GenIbet is able to accompany its customers from the early stages of a new drug development to the clinical phase. GenIbet combines strict compliance with GMP standards with a critical thinking and problem-solving mentality that allows it to create tailor-made solutions for each new customer and product.

GenIbet is inspected by INFARMED and holds a manufacturing authorization for the production of biopharmaceuticals and Experimental Medicinal Products. It is also audited by its clients, having already been audited more than 30 times by multinational pharmaceutical companies, always without any critical remark. In 2022 it is expected to be inspected by the FDA as part of the application for the submission of a License for a new biological drug.