At Aspen API we have extensive expertise and 100 years experience in large scale extraction and purification of biochemical products, in particular heparin sodium and chorionic gonadotrophin. We have established our own collection programs for starting materials using dedicated facilities and equipment for extraction and purification. This enables us to comply with the highest standards for API quality, traceability and viral safety.
Our biochemical capabilities
- Thanks to our long-lasting experience in the sourcing of raw materials from several continents, we have ensured full quality oversight, control and traceability.
- Our manufacturing processes include validated and approved viral and prion reduction steps.
- Through our in-house developed and validated real time PCR analysis technique, we certify the absence of bovine, ovine and caprine material in our heparin sodium.
- Continuously monitoring of and involvement in changing governmental regulations throughout the complete value chain.
