Cambrex unveils endotoxin removal system
endotoxin from protein production systems that it claims is
associated with less product waste than current procedures.
Endotoxin is a potentially fatal pyrogen that may be present in injectable drugs and vaccines, medical devices and the water for injection systems found in the pharmaceutical industry.
Cambrex' system, called EndoTrap, is an affinity matrix designd to remove endotoxin from aqueous solutions. It consists of a very high-affinity ligand material derived from bacteriophages, linked to sepharose beads, to create a column with endotoxin removal capability.
Currently available endotoxin removal methods frequently suffer from excessive loss of the protein during the process, making purification an expensive proposition. EndoTrap efficiently binds to endotoxin even at very low concentrations and minimises binding of the target protein due to the high ligand specificity, claims Cambrex.
The European Pharmacopoeia, along with its counterpart in the US, recently tightened up the acceptable limits for endotoxin contamination - used as a marker for bacterial contamination in products designed to be sterile - in both packaging and materials used in aseptic processing of drug products.
With EndoTrap, protein recovery in the range of 92-99 per cent is possible in most cases, says Cambrex, which maintains that the product is ideal for removal of endotoxin in cell culture supernatants, in-process material, and protein products.
EndoTrap is available in two versions: EndoTrap Blue and EndoTrap Red. Both versions have similar capabilities for endotoxin removal and selection is based on the ionic strength and pH range of the sample solution.
The product is shipped in ready-to-use columns. After removing the column cap, draining the storage solution and activating the column, the sample is applied. As the solution drains, the product is endotoxin-free. Afterwards, the endotoxin can be removed and the columns reused.
Endotoxin detection and removal is a core part of Cambrex' Biopharma division, which reported sales of $11.7 million in the second quarter of this year out of total group sales of $116 million. Cambrex has been steadily building the microbiological analysis and processing side of its business, through the acquisitions last year of France's Genolife and US firm Epoch Biosciences.
