AnalytischDenker schreef op 25 april 2020 18:52:
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Ik geloof er niets van dat purificatie een doorlooptijd heeft van 9 maanden. Marketing bullshit van Pharming.
When compared to a cell-line, a transgenic rabbit platform has many advantages. Once you create a founder generation, you have your final fully-structured protein in the rabbit’s milk, you have your bioreactor, and the protein is at its final concentration in the milk.
The production process is constant and instantaneous in a sense, as you can collect milk on a daily basis, unlike cell-line systems where it can take up to a few months to produce a single batch. As such, scaling up is relatively simple, and there are few challenges or hurdles to overcome, whereas with a cell-line system problems with the protein’s structure and yields are often encountered when you scale up production.Compared to other animals that can be used as transgenic platforms, rabbits are strongly preferred for a variety of reasons. Pharming was the pioneer in research on transgenic cattle, and we discontinued this research three years ago. Primarily this is because the protein content of a cow’s milk is much lower than many other animals, and thus yields of desired proteins are much lower. Rabbits are small, are easy to house and care for, have very high protein concentrations in their milk, and of course breed like rabbits, allowing production to be scaled up relatively quickly. Each rabbit produces 150-200 ml of milk per day, and we get yields of 12 grams of our C1 inhibitor protein per liter of milk. After purification, this equates to nearly three doses of Ruconest per rabbit per day.
Furthermore, rabbit milk can be frozen for up to three years before being purified into the drug substance, which itself can also be kept for three years, followed by the final production step (sterile Fill & Finish). The finished product (Vials) have a shelf life of four years at room temperature. This has allowed us to build up significant stocks in our freezers, with very low storage cost, without having to finance the expensive purification process. Managing our rabbits with proper husbandry only accounts for lees than 20 per cent of the overall cost of producing Ruconest, and given our ability to build up milk stocks we have quite a flexible and versatile supply chain. The milk of a cow or goat cannot be stored as easily, as the protein content is much lower, and the larger volumes make maintaining GMP standards more difficult.
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