Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
|Articles|November 2, 2016
- Pharmaceutical Technology-11-02-2016
- Volume 40
- Issue 11
Integrated Membrane for Single-Use Filtration Assemblies
Sartorius Stedim Biotech’s polyethersulfone membrane is now integrated into two new, sterile Sartocon benchtop and production-scale filtration assemblies.
Sartorius Stedim Biotech’s (SSB) polyethersulfone membrane (PESU) is now integrated into two new, sterile Sartocon benchtop and production-scale filtration assemblies. The fully enclosed design makes the Sartocon assemblies ideal for safely purifying vaccines and recombinant proteins, as well as monoclonal antibody manufacturing. The assemblies are suitable for use in cGMP environments for process development, clinical trials, and small-scale production batches.
Because 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 simple. The PESU membrane inside the Sartocon assemblies is available in several sizes, 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, prevent product cross-contamination.
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The Human Factor in Inspectionsalmost 10 years ago
Application of QbD and QRM to Analytical Method Validationalmost 10 years ago
Biosimilars to Drive Modern Manufacturing Approachesalmost 10 years ago
Cleaning Validation in Continuous Manufacturingalmost 10 years ago
Lubrication in Continuous Tubular Powder Blendersalmost 10 years ago
Dual-Shaft Mixers Provide Efficient Turnoveralmost 10 years ago
Biomolecule Separator Reduces Sample Absorptionalmost 10 years ago
Workstations Allow for Continuous Control of Cell Culture Processesalmost 10 years ago
Dissolution TestingRelated to this article
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