Project: Single-use glucose sensors for bioreactors and bioreactor

The Vision:_x000D_The vision of this project, glucoCELL, is to:_x000D_• develop and produce at series of system controlled small foot-print single-use bioreactors capable of obtaining extreme high cell densities >1x10E8 cells/ml over >30 days cultivation. The bioreactor do not contain extractables or leachables, and be able to demonstrate minimum 20-50 times higher productivity of safe biologics than state-of-the-art techniques and products using suspension cells._x000D_• develop a single-use standard size sensor capable of measuring the highly important process parameter such as glucose and lactate_x000D_• cell density in single-use bioreactor and the associated data transmitter system easy to connect to existing process control systems._x000D__x000D_The Background:_x000D_Biopharmaceutical drug medicines are among the most successful products in the pharmaceutical industry. The challenge is to produce these medicines cost effectively and safe. _x000D_Most biopharmaceutical productions involving products facing cyclic demands, such as vaccines, as well as most CMOs, contract manufacturing organizations, with the need for flexible production of different biologics with quick turnarounds, are heavily transitioning from production in fixed glass/steel reactors to production using disposable bags in an effort to address capacity bottlenecks as well as eliminate extensive regulatory work associated with cleaning and sterilization._x000D_The pharmaceutical process industries uses of sensors are vastly dominated by the use of standard PG13.5 dimension re-usable sensors suitable for SIP, CIP and autoclavable. A single-use PG13.5 dimension glucose and lactate sensor does simply not exist._x000D__x000D_A breakthrough in the field of cost efficient biopharmaceutical manufacturing technology used for manufacturing of safe biologics would strengthen the position of the European pharmaceutical industry._x000D_ _x000D_Approach:_x000D_To develop highly innovative, cost-efficient and safe controlled bioreactor and bioprocess sensors, the complementary expertise of the four project Ps, two R&D performing SME's (CerCell, Denmark and C-CIT, Switzerland), and a University with a long time recognition in the bio industry (ZHAW, Switzerland) is required._x000D__x000D_CerCell holds the IP rights to an attractive disposable perfusion bioreactor principle for adherent and suspension cells in a compact and scalable design. Under optimal conditions, mammalian cells are productive and depend on strictly controlled feeding and control systems. The bioreactor's environment should ensure access for every cell to nutrients (glucose, amino acids, etc.) and gases (i.e., air, oxygen, carbon dioxide). The bioreactor principles developed by CerCell do not give rise to the forming of gradients and could achieve very high cell density (>1x10E8 cells/ml) of also suspension cells. _x000D__x000D_C-CIT AG has a strong reputation for measuring glucose and lactate in fluids. Re-usable capacity cell mass sensors is a complex task to which Fogale is the strongest P in Europe with years of international sales._x000D__x000D_Zurich University of Applied Sciences is the largest units for research and education within mammalian cell bioprocessing in Switzerland and will be responsible for testing the ability of CHO cells to grow to the very high cell densities and produce recombinant antibody in the developed and controlled single-use bioreactor system including single-use sensors._x000D__x000D_Expected Results:_x000D_• a disposable bioreactor capable of obtaining high cell densities >1x10E8 cells/ml for more than 30 days_x000D_• a single-use sensor capable of measuring both glucose and lactate in one PG13.5x120 mm body_x000D_Both products ready to produce and bring to market combined as well as individual._x000D__x000D_The direct beneficiaries will be the participating SME's, who expect a substantial company growth as a result of this project, and the Institute who will enrich their research competencies as well as service offerings. The indirect beneficiaries will be the biopharmaceutical industry who will benefit from cost-efficient production of safe biologics.

Acronym	glucoCELL (Reference Number: 6936)
Duration	01/04/2012 - 01/09/2013
Project Topic	Development, prototype manufacturing and testing of cost-effective single-use sensors for on-line measuring of glucose and lactate in and prototype manufacturing of associated bioreactors for cultivation of eukaryotic cells such as human and mammalian cells
Project Results (after finalisation)	ST - the plan was as described "prototype manufacturing of associated bioreactors for cultivation of eukaryotic cells such as human and mammalian cells" in the application. _x000D_
Network	Eurostars
Call	Eurostars Cut-Off 7

Project partner

Number	Name	Role	Country
3	C-CIT AG	Partner	Switzerland
3	Stobbe Tech A/S	Coordinator	Denmark
3	Zurich University of Applied Sciences	Partner	Switzerland