Assemblies save up to 60 percent on processing time and offer a safe approach to ultrafiltration of biologics and vaccines
Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, today announced its polyethersulfone membrane (PESU) is now integrated 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 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. Both assemblies are supplied gamma sterilized 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 eliminates the costs of using buffers and purified water to prepare the membrane.
Since 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, linear scale-up and process transfer is 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 perfect for use in R&D applications, Contract Manufacturing Organizations and 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. 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 percent and could save up to 2,000€ per batch on buffer and water costs”, Frank Meyeroltmanns, expert for crossflow-filtration at SSB explains.