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International Therapeutic Proteins Ltd |
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International Therapeutic Proteins is headquartered in the UK. The UK office functions are primarily administration, distribution and regulatory affairs. The company’s subsidiary, Australian Therapeutic Proteins, owns two farms in Tasmania totalling 500 hectares (1,235 acres). These properties are in reliable rainfall areas and have comprehensive water storage facilities. The farms currently accommodate sheep, goats and cattle however horses (equine) and donkeys can be accommodated on request. Both properties are Australian Quarantine Inspection Service approved for export of blood products. Extremely high health status and standards of welfare are maintained on the farms by way of regular health screening and veterinary inspections. Immunisation and blood harvesting are conducted by trained technicians working to cGMP. Blood may be collected as natural clot or by plasmapheresis. All plasma or serum undergoes a Quality Assurance release procedure before being used for further processing. A dedicated protein fractionation facility is used for all antitoxin products. This consists of an upstream (pre viral inactivation) suite for the fractionation of IgG from whole serum or plasma and a downstream (post viral inactivation) suite to conduct further processing and formulation of the F(ab)2 fragment. The bulk finished product is currently sent to a contractor for sterile filtration, filling and freeze drying. This is performed by a leading European Contract Manufacturing Organization. ITP is fully licensed by the TGA of Australia for the manufacture of antisera in large animals for therapeutic applications and has a strong track record with European and US regulatory authorities. |
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