Rob Noel, Upfront Bioprocesses' business development manager, told in-PharmaTechnologist.com that the firm believes its technology can reduce development time and costs for manufacturers hoping to produce a variety of high quality MAbs.
The most commonly used MAb capture methods utilise packed bed protein A based adsorbents that require a series of complex filtration steps to extract the purified molecule during production.
Dr Noel explained that, as a result: "the MAb containing feedstream has to be separated of cells by centrifugation or microfiltration, followed by depth filtration, fine filtration and/or sterile filtration," adding that these are costly processes in terms of time, money and yield reduction.
He also said that the key feature of the system is the fact that it does not "generate back pressure because the adsorbent is fluidised [expanded], this has added advantages for operation of the disposable units."
He explained that "pressurised pumping systems used to operate packed bed chromatography systems tend to use stainless steel piping and other hardware that requires cleaning-in-place procedures; just what disposables are trying to avoid."
Noel went on to say that: "For pilot plants and CMOs the ability to remove all clarification steps has obvious consumable cost savings, but the key advantage could turn out to be time saved and simplification of a platform process. A disposable bioreactor could be processed such that within one day with the MAb product is stored in a purified state for the downstream step."
Data from ongoing beta test trials of the Rhobust technology suggest that it can recover around 10 per cent more MAb per batch than traditional filtration systems.
In addition, studies of the technology carried out by DSM Biologics indicate that the system can be used as part of a mixed mode adsorbent applied to a high cell density, high titre MAb feedstock.
These results, which were presented at June's Recovery Conference in Canada, show that no problems were reported using the unfiltered feedstock and that clearance of host cell proteins was close to that obtained by a clarified feedstock being applied to packed bed protein A.
While Upfront is targeting the biopharmaceuticals market initially, the company intends to provide different adsorbent functionalities in the disposable units to process other mammalian cell and microbial derived therapuetuics.
