Blood from farms
The Active Pharmaceutical Ingredient (API) eCG is produced from blood-plasma sourced from pregnant mares at a number of farms where horses are kept.
When a farmer wants to participate in the blood collection program, he/she should firstly contact Isteka that will assist in obtaining a permit from the Icelandic Food and Veterinary Authority (MAST).
A written animal welfare agreement must also be in place between Ísteka and a farmer before blood collection is started at his/her farm.
The farmers take care of their mares all year round. The mares are kept in adequately sized pastures with good grazing area and access to water. The horses are enabled to live in accordance with their natural behaviour patterns as much as possible.
Facilities used for the blood collection must be designed in a way to facilitate a smooth blood collection process for the mares. The staff must also be aware of the importance of appropriate behavior during the blood collection procedure, as the mares are more likely to be at ease when the atmosphere is peaceful and calm.
Licensed veterinarians extract blood from the mares, after giving them a a local anesthetic at the injection site. The vet checks the wellbeing and health of the mare before donation starts as blood is only extracted from healthy mares.
Following collection of blood at the farms, the containers are securely transported to the plasma separation facilities. The plasma is stored frozen for later processing while the blood cells are collected for upcycling.
The active pharmaceutical ingredient eCG is produced from the plasma in Ísteka's production plant in Reykjavík. The procedure involves a series of different down-stream protein purification steps including chromatographic separation methods. The purified product is filtrated and freeze-dried before packaging. The production is according to strict GMP standards with extensive testing in our laboratory in every step.
Production of a Medicinal Product
Pharmaceutical APIs and excipients are used to produce medicinal products in various forms such as tablets, injectables, and creams. This is done under strict GMP standards. Each unique medicinal product has its own specifically defined production method and its form is chosen based on the desired effect of the API and intended use.
Medicinal products containing eCG are powders for injection, dissolved in water before use. They are produced and commercialised by a number of pharmaceutical companies.