The newly-introduced technology can be applied in downstream analytics and product purification processes, providing retention of particles with sizes greater than the pore diameter, in order to prevent particle contamination.
According to the company, the filtration membrane enables antibodies and exosomes production at high volumes, to address hurdles often met during filtration, including adsorption, fouling, clogging, unwanted and unselective separation, and lack of multi-usability.
Andreas Koch, Securecell’s business unit manager, told us that the product has the potential to offer high and constant flow rate over a long period of time, due to its physical characteristics (thin membrane, defined pore size and pore distribution) and chemical surface properties (anti-fouling covalent coating).
According to Koch, other similar products that are available on the market tend to clog, and also do not offer precise size exclusion because their pore sizes vary around a given mean pore diameter value.
“Having precise size exclusion offers additional benefits when it comes to downstream processes,” due to the importance of preventing particles entering chromatography columns, the executive noted, adding that “true competitive systems rely on external hollow fiber filtration reactor cartridges.”
Moreover, the in situ membrane enables the filtration to occur within the bioreactor, without the need for the content to be circulated to distant external devices.
“Anticipated benefits are to be found in decreased cell lyses / disturbances based on circulatory processes affecting the complete cell culture,” Koch added.
The primary purpose of Sephara is the continuous production of antibodies and exosomes, as well as vaccines, with viral vectors being extracted out of cells through the pores, the sizes of which start at 0.2 um and can reach up to 2.2 um.
However, Koch told us that the company also looks to extend its application to the development of cell therapies, including chimeric antigen receptor (CAR)-T and stem cell therapies, using the widest possible pore size (2.2 um) for the filtration of whole cells.
Sephara is suitable to be integrated to bioreactors of approximately 3L size, allowing a process able to support “a certain number of patients, but not the global demand,” Koch told us. As a result, the product is recommended for early-stage clinical manufacturing purposes.
The executive explained that, in order to apply Sephara to ‘larger vessels’, the company would have to increase the surface of the membrane. However, Securecell aims to answer the current market demand related to personalized medicine, with developers looking to ‘scale-out’ rather than ‘scale-up’.
“Initially, our probe will be launched as a multi-use probe. Our plan is to come out with a single-use Sephara probe,” Koch noted, adding that the company is looking for a single-use bioreactor manufacturer to partner with for that purpose.