Instituto de Biologia Experimental e Tecnológica (iBET)

iBET is a private non-profit research-intensive institution founded in 1989 with the mission to integrate and strengthen biological and biochemical knowledge from its academic and industrial partners and transfer technology to the market. IBET brings together, as partners and collaborators, private companies and public institutions, creating a critical mass of competencies for product and process development. Science and technology are used to accelerate the translational application of competences from early-stage discovery to final production and processes. iBET’s know-how, in terms of biopharmaceuticals, spans from the initial expression vector design and cell line establishment through all stages of process development and scale-up (production, purification, stability and storage). IBET has coordinated more than 30 international projects, has participated as a work package leader in more than 50 EC projects, and has also carried out many further projects for industry clients. Recently, iBET became the coordinator of a research unit funded by FCT, iNOVA4Health, a translational medicine program organising the efforts of biomedical researchers involved in biological understanding of disease, lead compounds and biopharmaceuticals (pre-discovery), technological scientists involved in preclinical development, and clinicians involved in early clinical and first-in-man clinical trials.

Role in the TRANSVAC project

iBET will be represented by senior experts from its Animal Cell Technology Unit (ACTU). One of the focus areas of the ACTU is rational process development for complex biopharmaceuticals, in particular the production of vaccine candidates (e.g. subunit recombinant proteins, viruses and virus-like particles - VLPs) for human and veterinary use based on insect and mammalian cell lines. These activities have been developed within both EC-funded and industry-funded projects, involving large companies (Novartis, MSD) and small start-ups (LETI, ALLOKSYS, VCN, GENETHON, CEVEC). Competencies include upstream and downstream processing, where IBET has also participated in developing and testing single-use equipment for Sartorius-Stedim Biotech, GE Healthcare, Merck Millipore, PALL and LONZA. iBET will be involved in WP7 (cross-platform screening and optimisation service) and WP10 (pre-clinical GLP production services). In WP7, iBET will be involved in activities connected with mammalian and insect cell expression platform screening, and small-scale production and purification of candidate vaccines. In WP10, iBET will be involved in the GMP-directed evaluation of vaccine candidate production processes, production scale-up for vaccine candidates, definition of specifications for pilot-scale production, product stability testing and delivery for GLP toxicology studies, as well as the evaluation of development, manufacturing and finishing documentation.

Main staff involved in TRANSVAC

Paula Alves, iBET CEO/ACTU Director; Manuel Carrondo (iBET Founder, Professor of Chemical and Biochemical Engineering, Head of the Engineering Cellular Applications Laboratory ACTU; António Cunha, iBET Pilot Plant Director; Ana Sofia Coroadinha, Head of ACTU Cell Development Laboratory;Cristina Peixoto, Head of ACTU Downstream Process Laboratory; Antonio Roldão PhD, ACTU Vaccine Area;

The Facility

iBET’s infrastructure comprises 16 laboratories fully equipped with state-of-the-art technology (70 m2 each), including a BSL2 laboratory for working with viruses; a GMP Analytical Services Unit certified by the INFARMED (the Portuguese medicines authority, EMA Portuguese branch) and by DGAV (the Portuguese veterinary authority) for quality control and batch release of human and veterinary pharmaceuticals, biopharmaceuticals as well as experimental new drugs; a GMP Mass-Spectroscopy Unit that provides state-of-the-art MS services to the scientific community and Industry; a 2600 m2 bio-pilot plant supporting production and purification of proteins ATMPs and vaccines from bench top to 300 L scale and privileged access to GeniBET Biopharmaceuticals, an iBET spin-off producing ATMPs under cGMP certification for phase I/II/III clinical trials. Supporting researchers, iBET has a core Infrastructural Unit, including an Administrative Department that deals with all aspects of administrative and financial support to research projects and contracts with the industry, including support in technology transfer and intellectual property rights; a Marketing and Business Development Department and a Human Resources and People Development Office.

TNA or Training provided

iBET will be involved in WP7 (cross-platform screening and optimisation service) and WP10 (pre-clinical GLP production services). In WP7, iBET will be involved in activities relating to mammalian and insect cell expression platform screening, and small-scale production and purification of candidate vaccines. In WP10, iBET will be involved in activities relating to GMP-directed evaluation of vaccine candidate production processes, production scale-up for vaccine candidates, definition of specifications for pilot-scale production, product stability testing and delivery for GLP toxicology studies, as well as the evaluation of development, manufacturing and finishing documentation.

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