The facility is Samsung BioLogic’s ‘Plant 3’ (pictured), which is located in Songdo, South Korea, and has a 15,000L commercial production capacity.
Last month, the contract development and manufacturing organization (CDMO) announced that it had been able to perform an N-1 perfusion with alternating tangential flow (ATF) device and the technology’s adoption could potentially reduce “production time by up to 30%” for its clients.
The ATF perfusion system means that the CDMO is able to cultivate higher cell culture densities, up to 10-fold, within shorter culture durations.
It is able to achieve this through the use of hollow fiber membranes filtering growth medium from mammalian cells, with the alternating flow then returning cells to the bioreactor.
Further than this, “The spent growth medium is discharged, whilst fresh growth medium is continuously added to replace the spent medium at the same rate,” the company stated.
This allows the process to be semi-automated, with manual intervention ‘reduced to a minimum’ through the cultivation period.
The validation of the ATF system took Samsung BioLogics six months to complete and will now allow for commercial cell culture expansion, compliant with current good manufacturing practice (cGMP) standards.
Last year, the overall Samsung organization announced that it would be investing significant sums into its business, with a portion of this used towards the CDMO business.
Following this, the CDMO has announced partnerships to develop customers’ molecules, which now sees the company holding agreements with nine domestic and overseas companies.