Some Active Ingredients have such a complex structure that they are too difficult and expensive to synthesize on an industrial scale. Such compounds can be isolated, however, from natural sources. The ease with which the active compound can be isolated and purified depends very much on its structure, stability and the concentration of the compound in the natural source. Heparin sodium is derived from porcine intestinal tissue.
The average molecular weight of most commercial heparin preparations is in the range of 12 kDa to 15 kDa. Heparin is a member of the glycosaminoglycan family of carbohydrates. Heparin is given parenterally because it is not absorbed from the gut, due to its high negative charge and large size. Heparin can be injected intravenously or subcutaneously.
Aspen Oss has extensive expertise of over 90 years in large scale extraction and purification of biochemical products, in particular Heparin sodium from natural sources.
Having such extensive experience in producing Heparin sodium, we are perfectly aware of the increasing demands from international regulatory authorities on the API quality, and are proud to inform that we 100% comply with the current quality and regulatory standards, and support the EMA and FDA position papers focusing on full cGMP production in future.
Also, we are completely focused on supplying the best quality Heparin sodium to the market, putting the safety of patients first.
- we control by having own collection programs for starting materials in Europe and North-America (including own audit and control programs)
- we continuously monitor and analyze the impact of animal diseases
- we source only from authorized slaughterhouses and from healthy animals intended for human consumption
- we have installed quality control measures to avoid cross contamination
- we ensure full traceability
- our processes include validated viral inactivation and prion reduction steps to secure viral and prion safety
- we certify the absence of ruminant material using a validated qPCR analysis technique
Aspen Oss meets the latest pharmacopeia and guidelines and will make sure to comply 'tomorrow' as well
- we release Heparin Sodium according to the latest pharmacopeia (EP, USP, JP), including SAX-HPLC and NMR analysis to certify absence of Oversulphated Chondroitin Sulphate (OSCS)
- we manufacture the complete process according to cGMP from raw material to Heparin API
- we are successfully audited by FDA, PMDA and Dutch Health Authorities
- we follow (draft) position papers issued by FDA en EMA
- we participate in calibration studies for new methods or specifications proposed by USP, EP or JP