Current regulations insist that a mammalian cell biopharmaceutical manufacturing process must contain two related methods to remove contaminating viruses one of which must be filtration. Failure to comply would result in a significant risk to patients from viral infection.
The two most widely used methods are viral removal and viral inactivation. Viral removal is a method in which all viruses are simply removed from the sample completely whereas viral inactivation is one in which the viruses may remain in the final product, but in a non-infective form.
Viruses can be removed by incubating the process stream in a holding container for some time (such as an hour) under conditions that deactivate viruses without damaging the product. These conditions include extremes of pH or the presence of a detergent. A virus filtration will also be employed towards the end of the process to filter out any remaining viruses. This is typically accomplished using composite membranes that provide the required combination of virus retention and mechanical stability.
Current virus-retentive filters are ultrafilters or microfilters with very small pores. Virus filtration membranes are made from hydrophilic PES, hydrophilic PVDF and regenerated cellulose. According to the size distribution of viruses that are removed, virus filters can be categorized into retrovirus filters and parvovirus filters.
- Tubing assemblies
- Carboy assemblies
- Single-use Bottle assemblies
- Biopharmaceutical TPE tubing; to create a sterile closed system for transporting the formulation site.
- Silicone tubing.
- Pump-grade tubing has been developed for peristaltic pumps. It is designed to have a longer pump life.
- 2D and 3D Single-use bioprocess bags are available up to 2000L and are designed for the preparation, storage and transport of buffers and biopharmaceutical solutions.
- 2D Rockerbags for cell culture applications.
- Cryo bags are available for up to 20L to store biopharmaceutical products at -85°C.
- Quattroflow single-use pumps deliver the required levels of product purity and sterility these applications demand, eliminating the chance of harming the product and decreasing the odds of costly cross-batch or cross-product contamination.
Plastic Fittings & Connectors
- Sterile connectors are an alternative to welding and sealing. They can be used to make a sterile connection between tubing.