GenIbet Biopharmaceuticals is a GMP biopharmaceutical Contract Development Manufacturing Organization (CDMO) offering highly specialized manufacturing and development services to support worldwide partners on building the therapies of the future.
Founded in 2006 GenIbet was the 1st Portuguese CDMO to supply Biopharmaceuticals for Clinical Trials. GenIbet was also the 1st Portuguese company to obtain a Good Manufacturing Practices (GMP) certification, recognized by the European Medicines Agency, to produce Biological Investigational Medicinal Products (IMPs).
GenIbet core activity is the manufacture and supply of materials for use in early-stage drug development, pre-clinical studies, and GMP manufacturing for clinical trials. This, combined with in-house fill and finish capabilities, gives GenIbet the ability to provide its clients with the opportunity to go from bench to clinic with a single partner.
GenIbet offers a unique combination of strict GMP compliance, critical thinking, and problem-solving mindset which are critical to provide Tailored Solutions to develop the therapies of the future.
GenIbet expertise covers a broad spectra of Biopharmaceuticals development and manufacturing, including biological banks of mammalian and insect cells, bacteria, yeasts and virus, Cell and Gene Therapy products, Live Microbial Products, Recombinant proteins, RNA and Vaccines. In particular GenIbet has been involved in the manufacture of vaccines, including RNA vaccines for Moderna, several malaria vaccines candidates, oncolytic viruses and microbiome therapies.
GenIbet is dully qualified by the Portuguese regulatory authorities (Infarmed) for biopharmaceuticals production and manufacture of Investigational Medicinal Products (IMPs) and has hold more than 30 audits from major companies, always with very good results. An FDA inspection is due to occur in 2022 as part of the submission of a new Biologics Licensing application.