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European Biopharmaceutical Review

Bioprocess Facilities: The Disposable Revolution

According to Rodolphe Renac, Xavier Pinardon and Xavier Revest at Alcimed, the technological breakthroughs regarding disposable technologies for biodrug production will deeply change the current biomanufacturing practices of biopharmas, biotechs and contract manufacturing operators

Today, about 50 per cent of new marketed drugs come from biotechnology (1). In addition to the R&D costs, which are higher than those for pharmaceutical chemistry-based molecules, one of the main issues for developing biodrugs companies is production cost. A biomanufacturing unit for commercial batches represents an average investment of €300-500 million and requires between three and five years to acheive factory qualification.

A gap exists between big pharmas equipped with their own biomanufacturing capacities and small- or mid-size biotech or biopharma companies without such facilities which depend on the CMO services. Regardless of their differences, the trend of all biodrug developers is to reduce the cost of manufacturing for their clinical and commercial batches – disposable devices are therefore highly relevant.

Single-use disposable technology is full of promise from an economical point of view; they avoid cleaning, prevent cross-contamination risks and reduce the systematic production line qualification procedures following each batch release. Total savings incurred by switching from a stainless steel production line to a single-use line are estimated to be more than 30 per cent with the disposable technologies currently available.

However, building an exclusively disposable device-based biomanufacturing factory does not yet appear possible. Despite wide-spread integration in biomanufacturing of silicon-based pipes, the development of disposable bioreactors (for production via mammalian cells, CHO type) as well as disposable fermentors (for the production via microbial cells, E Coli type) is not yet fully achieved.


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Rodolphe Renac is a graduate from the National Superior Chemistry School of Montpellier, France, with an MSc in Biochemistry and Molecular Biology from Boston University and the University of Louisiana. He did his thesis on Molecular and Clinical Oncology, before participating in two biotechnology start-ups in San Diego, US. He joined Alcimed in 2000, first as a Consultant, then developing new business activity and is now the Director of Alcimed’s Biotechnology and Innovation Business Unit.

Xavier Revest graduated from the French Grande Ecole of Engineering Centrale, Paris, with a double specialisation in Health and Biotechnology and Marketing, Strategy and Finance. He has been responsible for the commercialisation and marketing of innovative diagnostic tests in a biotech start-up, focusing on pathogenic blood contamination. Today Xavier is Project Manager in the Biotechnology and Innovation business unit of Alcimed, where he tackles strategic issues regarding the biomanufacturing of monoclonal antibodies and recombinant small proteins in the fields of haemostasis, immunology and oncology for the European and US decision-makers of pharma and biotech companies.

Xavier Pinardon is an Engineer specialising in the life sciences. He is a Consultant in the Biotechnology and Innovation business unit of Alcimed, where he has performed duties for a variety of European biotech and pharma companies, predominantly in the biomanufacturing field – concerning disposable technologies implementation strategies in biodrug production plants for antibodies and recombinant proteins producers, technology positioning analysis, business models orientation and marketing strategy definition for disposables device manufacturers.

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Rodolphe Renac
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Xavier Revest
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Xavier Pinardon
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