Ambipro Technical Information

TSE is a generic term used to describe progressive neurodegenerative disease caused by an unusual, infectious agent. TSEs are generically referred to as "prion diseases".

A number of biopharmaceuticals manufactured today still use a wide range of raw materials sourced from animal byproducts. Many of these animals/raw materials are bovine- and ovine-sourced components that may be subjected to TSE risk in the form of BSE or scrapie. Because BSE and other prion diseases have defied the basic tenets of scientific knowledge and demonstrated that no universal dogma can be applied, risk reduction and risk management must therefore be addressed.

Ambipro ensures that mechanisms that negate the risk of infection are in place. A strategy of sourcing (country of origin and method of collection), types of material used (tissue or organs) and processing methodologies that could inactivate or remove the TSE agents are implemented.The line of attack adopted by Ambipro is outlined below:

BSE (TSE)-FREE
PRODUCTS SOLD BY AMBIPRO INC.

Chymotrypsin, Trypsin, Deoxyribonuclease, Ribonucelase and Hyaluronidase
All the above products are extracted from glands obtained from BSE (TSE)-free countries [as classified by the Office Internationale des Epizooties (OIE) and as regionally demarcated by the USDA], namely New Zealand, Australia and South Africa.
The slaughter and collection processes are under government veterinary supervision, and are in accordance with USDA and EEC requirements.
Only glands (of the low to non-detectible category) are collected from animals which have passed veterinary post- and ante-mortem inspection and been approved as fit for human consumption can be used for subsequent processing.
Precise procedures are in place, describing the removal of skull, vertebrae and spinal cord during the collection of the pancreatic glands and testes. Accordingly, brain and nervous tissue do not come into contact with the pancreas and testes during the removal of these organs from the carcass.
The livestock have not been fed bone meal, meat or other ruminant tissue.
Traceability of materials is ensured by strict adherence to documentation requirements.
The glands are subjected to acid/freeze treatment immediately upon removal from the carcass.
The glands are further subjected to extended acid treatment during enzyme extraction.
Veterinary certificates and country of origin certificates accompany each shipment.
The manufacturing facility is GMP and ISO 9002 certified.
The manufacturing plant also has certification of suitability of monographs of the European Pharmacopoea (EDQM).
Reference: Pharmacopoea Supplement, May, 2002