EndoTrap® HD for endotoxin removal in biomanufacturing process is launched by Profos
Endotoxins (Lipopolysaccharides, LPS) derived from Gram-negative bacteria constitute a significant problem in research and development as they have an immunogenic as well as a toxic component. Endotoxin contamination of drugs and vaccines originated from cell or bacterial culture is a major issue for pharmaceutical industry. In humans endotoxin induces potent pathophysiological effects; therefore drugs and vaccines will be accepted for sales only with a low level of endotoxins.
For this purpose Profos has developed the new EndoTrap® HD LPS removal system which meets the challenges of biomanufacturing process combining highly specific LPS removal with high regeneration abilities and a dimensionally stable affinity matrix, which can be integrated into the downstream purification process of biomolecules.
Furthermore the EndoTrap Leakage ELISA (Enzyme Linked Immunosorbent Assay), a two-step sandwich enzyme-linked immunosorbent assay for the quantitative determination of the EndoTrap® HD ligand in biological aqueous solutions, will be available from now on. Together with the Regulatory Support File Profos provides comprehensive information about EndoTrap® HD affinity matrix to help customers register their production processes.
Dr. Stephanie Steck, in charge of the enlargement of the EndoTrap®-family: "With our products "EndoTrap® blue" and "EndoTrap® red" which both are established on the global markets for endotoxin removal we have successfully been serving the needs of our customers especially in academia and research. But we observed an increasing demand for a specific endotoxin removal system for large scale purification processes. With our new product "EndoTrap® HD" we are convinced to having created a product that fully satisfies these requirements of our customers."
With EndoTrap® HD, Profos has taken the next step to become a global market leader in the field of endotoxin removal systems and high-quality endotoxin-free products. Further products are in development and will expand the portfolio continuously.
Profos AG, founded in 2000, employs a total of 58 permanents staff and is certified according to ISO 9001:2000 and ISO13485:2003. Profos’ core competency is to exploit the principles of bacteriophage biology for pharmaceutical, diagnostic and research applications.