EMD Millipore and PharmaCell B.V. have entered a collaboration to develop optimized large-scale expansion and harvest of HepaRG cells using bioreactor technology. The companies aim to produce protocols and methods for efficient expansion, harvest and use of HepaRG cells to support the BALANCE project, which is funded by the Seventh Framework Program of the European Committee to create bioartificial livers.
The project is expected to deliver scalable expansion for the production of large-scale stem cell therapies, which is necessary for advancement into human clinical trials and to deliver the quantities efficiently and effectively. This will require further progress in the areas of cell culture and scale-up, characterization, enrichment and purification to deliver a consistent and reproducible supply of cells. PharmaCell provides GMP contract manufacturing services and process development solutions in the area of cell therapy and regenerative medicine. They will be using the Mobius bioreactor platform to support the project.
"As more cell-based therapeutics progress towards clinical testing, the consistency, quality and reproducibility of large-scale culture systems become an imperative," said Robert Shaw, commercial director of EMD Millipore's Stem Cell Initiative.
"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."
"We are excited to work with EMD Millipore to develop the future technologies for large-scale industrial production of human cells. EMD Millipore's world-class technical expertise in bioreactors combined with PharmaCell's advanced know-how in culturing human cells positions the team well to create solutions to overcome some significant technical hurdles in the field and lower future cost of goods sold for our clients," said Alexander Vos, chief executive officer, PharmaCell BV.