Assemblies save up to 60% on processing time and offer a safe approach to ultrafiltration of biologics and vaccines
The single-use Sartocon Self-contained Filter Loop Assembly has been developed for use with SSB’s control unit, the FlexAct UD
Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, has integrated its polyethersulfone membrane (PESU) into two new, sterile Sartocon benchtop and production scale filtration assemblies. Using these assemblies guarantees rapid and safe ultrafiltration of biologics and vaccines.
Due to the fully enclosed design, the company says the Sartocon assemblies are ideal for safely purifying vaccines and recombinant proteins, as well as monoclonal antibody manufacturing. This makes them suitable for use in cGMP environments for process development, clinical trials and small-scale production batches.
The new single-use Sartocon Self-contained Filter Loop Assembly has been developed for use with SSB’s unique control unit, the FlexAct UD, while the Sartocon Slice Self-contained Bag Loop Assembly has been designed for SSB’s benchtop crossflow system SARTOFLOW Alpha plus SU.
The Sartocon Slice Self-contained Bag Loop Assembly has been designed for SSB’s benchtop crossflow system SARTOFLOW Alpha plus SU
Both assemblies are supplied gamma sterilised and ready to use. The integrated PESU membrane is pre-wetted and flushed, which saves hours in set-up and validation time, as well as eliminating the costs of using buffers and purified water to prepare the membrane.
The Sartocon assemblies are designed with the same hydrodynamic flow path as SSB’s larger production scale filter devices and all device materials and accessories are manufactured to the same industrial quality-assured specifications, making linear scale-up and process transfer a simple process.
The PESU membrane inside the Sartocon assemblies is available in several sizes and 10-300 KDa molecular weight cut-offs and is robust enough for use in broad pH and temperature ranges. These features combined with the Sartocon assemblies’ single-use design, which prevents product cross-contamination, means they are suitable for use in R&D applications, by contract manufacturing organisations and in multi-product facilities.
'Following on from the successful introduction in 2015 of the Hydrosart membrane in our single-use Sartocon filter loop assemblies, we made our PESU membrane for these applications available as well. Now customers can select from a broader range of membrane polymers and cut offs for ensuring optimal parameter for their specific process,' said Frank Meyeroltmanns, expert for crossflow-filtration at SSB.
'When compared with reusable filter cassettes, we estimate that using these new single-use, PESU membrane-based assemblies will reduce processing time by around 60% and could save up to €2,000 per batch on buffer and water costs.'