EMD Millipore, the life science division of Merck KGaA, and PharmaCell will be collaborating to develop optimized, large-scale expansion and harvest of HepaRG cells using bioreactor technology, EMD Millipore said in a May 21, 2013 press release. The companies will work together to produce protocols and methods for efficient expansion, harvest, and use of HepaRG cells in support of the BALANCE project, which is funded by the Seventh Framework Programme of the European Committee and aims to create bioartificial livers to treat acute liver failure.
While large-scale methods to produce cells have typically used multilayer flasks, this project will examine bioreactors. The project is expected to deliver scalable expansion and harvesting devices, validation methods, and associated protocols for the production of large-scale stem-cell therapies.
Large-scale production of cells is necessary to enable their advancement into human clinical trials and to effectively deliver the quantities efficiently and effectively. Achieving this level of production while meeting rigorous quality standards will depend on further progress in the areas of cell culture and scale-up, characterization, enrichment, and purification to deliver a consistent and reproducible supply of cells.
"As more cell-based therapeutics progress towards clinical testing, the consistency, quality, and reproducibility of large-scale culture systems become an imperative," noted Robert Shaw, commercial director of EMD Millipore's Stem Cell Initiative, in the press release. "The ability to ensure that a population of cells can be reproducibly produced in a manner that can be validated is critical to the success of clinical applications. The technologies developed as part of this collaboration will help enable this and move the field forward."