Commercial N-1 perfusion carried out by Samsung BioLogics

CDMO Samsung BioLogics has used an Alternating Tangential Flow (ATF) system to perform N-1 perfusion at its 180,000 L facility in South Korea.

Contract development and manufacturing organization (CDMO) Samsung BioLogics opened its number 3 facility at its site in Songdo, Incheon last year, boasting 180,000 L of commercial stainless steel bioreactor capacity.

This month, the firm has announced it has successfully carried out N-1 perfusion with an Alternating Tangential Flow (ATF) system at the 3,000 L scale to supply the 15,000L commercial bioreactor.

According to a spokesperson from the CDMO, a perfusion system had always been designed within the plant to offer its clients a broader range of biomanufacturing services.

And while the particular client has not been named, Samsung BioLogics claims the use of perfusion has reduced their production time by up to 30%.

“The ATF perfusion system at SBL [Samsung BioLogics] allows for the CDMO to cultivate higher cell culture densities (up to 10 fold) whilst retaining high cell viabilities (>98%) at the seed stage (N-1) to enable inoculation of the production bioreactors (15,000L) at higher cell densities and achieve peak cell densities within shorter culture durations. This allows for improved productivity and reduction in production time, a significant benefit to clients,” the company said in a statement.

“During perfusion mode, ATF works continuously by utilizing hollow fiber membranes to selectively filter growth medium from mammalian cells with alternating flow to return cells to the bioreactor.

“A diaphragm pump provides the alternating flow and a low shear environment to minimize cell damage. The spent growth medium is discharged, whilst fresh growth medium is continuously added to replace the spent medium at the same rate. The fresh medium allows for continued cell growth and higher cell densities.”

Over the past few months, Samsung BioLogics has announced deals with several clients including UCB and CytoDyn.

But while the firm has been increasing utilization across its 360,000 L plus site, the CDMO has hit the news for all the wrong reasons due to accusations of accounting fraud. Litigation is ongoing, but a full summary of a yearlong investigation can be found here.