cGMP Manufacturing
GenIbet GMP manufacturing units focus on process robustness and consistency to ensure product quality, purity and efficacy. Our multi-products manufacturing facilities feature state-of-the-art equipment for l, animal cells derived viral and microbial products for clinical trials phase I-II in accordance with cGMP guidelines.
GenIbet GenIbet facility is routinely inspected by the local Portuguese Regulatory Authority – Infarmed – since 2009 and holds a Manufacturing Authorization for biopharmaceuticals production and manufacture of Investigational Medicinal Products (IMPs). Moreover, over the last 10 years GenIbet has hold more than 30 audits, including Astra Zeneca, Alexion, PPD, Merck, GSK and Novartis, without any critical observations.
GenIbet is approved for the manufacture of:
- Sterile and non-Sterile Active Pharmaceutical Ingredients, namely Polysaccharides, Recombinant Proteins, Plasmid DNA, Virus and Virus like Particles, Cell banks, Viral banks, in vitro Transcribed RNA, Live Microbial Products, Vaccines and other Immunological Products;
- Sterile and non-Sterile Human Investigational Medicinal Products (Cell therapy products, Gene therapy products, Immunological products, Biotechnology products, Human origin products and Advanced Therapy Medicinal Products (ATMPs)).
