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Using Alternating Tangential Flow in a 3000-L perfusion bioreactor, the company expects to reduce production time by up to 30%
At its manufacturing site in Songdo, South Korea, Samsung BioLogics (SBL) has demonstrated the viability of using alternating tangential flow (ATF) technology in a perfusion reactor at commercial scale. ATF perfusion has been applied in clinical development projects at small scale, according to SBL, but few companies have used the approach at large scale. The company said in a press release issued on August 12, 2019 that this approach should reduce production time by up to 30% for its client.
The new technology adds to the manufacturing options that the contract development and manufacturing organization (CDMO) can offer its biopharmaceutical manufacturing clients. According to SBL, the ATF perfusion system allows for a 10-fold improvement in cell culture densities while retaining cell viabilities of over 98% at the seed stage. This enables inoculation within 15,000-L bioreactors at higher cell densities, enabling peak cell densities to be achieved within shorter culture durations.
During perfusion, ATF uses hollow fiber membranes to filter growth medium from mammalian cells continuously, using alternating flow to return cells to the bioreactor, the company explained in the press release. A diaphragm pump is used to maintain a low-shear environment to minimize any cell damage and to provide alternating flow.
During the process, used medium is discharged and replaced with new medium at the same rate. SBL has been able to maintain a perfusion rate of up to three vessel volumes per day by using three 11-m2X-Cell ATF-10 systems, developed and sold by Repligen.
Other parameters such as cell volume, temperature, dissolved oxygen, and pH are kept constant, and SBL has automated the perfusion process by integrating the ATF system with bioreactor control.
The company notes that alternate technologies such as tangential flow filtration (TFF) may also be used for perfusion, with flexible flow paths.
Samsung worked closely with the ATF system vendor to design the stainless-steel-housed system, and to assure closed-system integrity and full compliance with current good manufacturing practices (cGMPs). Validation, including ATF system water and media tests as well as extensive autoclave cycle development and sterility performance testing, was completed within six months, the company disclosed in its press release.
Samsung expects to reduce consumable cost with the stainless steel ATF filter, although its engineering experts note that single use ATF filters can also be applied in the future.
Source: Samsung Biologics Press Release