GenIbet´s launching partner was the Novartis Institute for Global Health (NVGH), now GSK Institute for Global Health, with whom GenIbet collaborated on the development and manufacturing of a Typhoid Fever Vaccine, transferred to India in 2010 that ultimately led to the approval of this new medicine on the Indian Market in 2020. Other relevant partnership includes the development and manufacturing of a new veterinary vaccine against leishmaniasis, which was transferred from GenIbet to the commercial partner in 2011 and was approved by the European Medicine Agency in 2016.
GenIbet’s experience with other innovative biological medicines and advanced therapy medicinal products includes the Process Development and GMP manufacturing of Oncolytic Viruses, that selectively target tumor cells, and can be used on the treatment of different cancer types. There are several ongoing early-stage clinical trials, both in Europe and in the USA, which use materials manufactured and certified by GenIbet.
GenIbet facility is routinely inspected by the local Portuguese Regulatory Authority – Infarmed – since 2009 and holds a Manufacturing Authorization (F053/001/2019, Eudra GMP reference number 31130) for biopharmaceuticals production and manufacture of Investigational Medicinal Products (IMPs). Although GenIbet has not yet been inspected by FDA (as FDA does not inspect sites prior to BLA approval) we have had 2 GAP assessments performed in view of a future FDA inspection in partnership with one of our US clients. No critical gaps were identified during these assessments. Moreover, during the last 10 years GenIbet has hold more than 30 audits, including Astra Zeneca, Alexion, PPD, Merck, GSK and Novartis, without any critical observations.
On the vaccines field GenIbet has been actively engaged with the University of Oxford/Jenner Institute on the scale up and GMP manufacturing of several of their malaria vaccine candidates, two of which are already being used in Clinical Trials. In addition, GenIbet partnered with Moderna at an early stage, having manufactured their very first mRNA vaccine candidate to reach clinical trials. As stated by Moderna´s CEO, Stephane Bancel, “Moderna is very thankful to GenIbet Biopharmaceuticals. They partnered together to take the very first Moderna mRNA vaccine in the clinic at the end of 2015. The GenIbet team provided Moderna with a high quality GMP product and we are thankful for its work.”
