A CGMP bridge to personalized medicine
GenIbet Biopharmaceuticals (now Advanced Bio in Oeiras and part of the Recipharm Group) is a Contract Development Manufacturing Organization (CDMO) that offers highly specialized services for the development and production of biological products in accordance with the Pharmaceutical Industry’s Good Manufacturing Practices (GMP). Founded in 2006, GenIbet is a pioneer in its field, having been the first Portuguese company to obtain a manufacturing authorization for experimental biological medicines, 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, over the years, been a partner of several companies and research centers in the manufacture of vaccines and other biological products, including mRNA vaccines for Moderna; vaccines for Malaria, recombinant proteins using different expression systems, oncolytic viruses, and microbiome therapeutics.
In 2023, following a collaboration that began in 2014 with Seres Therapheutics, GenIbet received FDA approval for the commercial production of the first oral drug in the area of the microbiome for the treatment of recurrent Clostridioides difficile infections (rCDI) – VOWST.
GenIbet is inspected by INFARMED and holds a manufacturing authorization for the production of biopharmaceuticals and Experimental Medicines. It is also audited by its clients, having already been audited more than 30 times by multinational pharmaceutical companies, always without any critical remark.
GenIbet was acquired at the beginning of 2022 by the Recipharm Group, becoming part of the biological products unit of this pharmaceutical multinational – ReciBio. This business unit is responsible for 3 other sites in addition to GenIbet, 2 in the United States and 1 in Germany.
Thanks to the end-product filling capabilities available, GenIbet is able to accompany its customers from the early stages of developing a new drug through to the clinical phase and, with the recent FDA approval, the commercial 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.
