GenIbet Biopharmaceuticals (GenIbet) is a GMP CDMO offering highly specialized GMP manufacturing and development services to research groups, Biotech and Pharma companies. 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.
GenIbet runs projects within a very broad spectrum, including not only Cell and Gene Therapy products, but also Recombinant proteins, Vaccines, RNA and Live Microbial Products.
The GenIbet team has experience with mammalian, avian and insect cells, bacteria & yeasts and Viruses and a proven track record with A549, CAP, CHO, EB66, HEK293, SF9, MDCK, Vero, E. coli, Pichia pastoris, Baculovirus and Adenoviruses.
Our mission is to manufacture safe and reliable breakthrough products to support worldwide costumers on building the therapies of the future. We offer a unique combination of strict GMP compliance and troubleshooting/problem solving mindset which is crucial for early stage product development and believe on tailor made solutions for each specific product.
Main role in the project
GenIbet will be responsible for the GMP production of a Master Cell Bank (MCB) of Escherichia coli BL21 and of the Traspain Drug Substance for a phase 1 clinical trial. The GMP MCB will be used throughout process development and in the production of Traspain for the toxicology and clinical lot. For the clinical lot, a Master Batch Processing Record will be prepared, detailing all steps of the manufacturing process, which will be used in the cGMP production of the clinical batch and will be included for the IND submission.
Contact : Ana Alves
This project has received funding from the European Union’s Horizon 2020 research and innovationprogramme under grant agreement No 815418.