QDIS Blog

Seems Europe has approved ATryn (an anticlotting drug) which is produced in the milk of genetically modified goats. GTC Biotherapeutics is the company behind this although Genyme is representing them in European regulatory issues.

Reuters: Goat-derived drug cleared in Europe
Boston Globe: GTC gets surprise boost from EU

The clinical trials in the US are almost compete and it should go to the FDA sometime in the first half on 2007. The process involves inserting a gene into the goat before they are born which causes them to produce a human protein that can be purified and tuned into an injectable drug for humans. The disease ATryn treats is fairly rare (about 60,000 cases in the US or about 1 in 5,000) and therefore an excellent candidate to be produce in animals. The economics of producing this complex of a product in a standard biotech factory would most likely be prohibitive with that few patients.

This situation, where an animal is used to produce a drug, has lead to the term “pharming” since the goats are in essence a walking, eating drug factory. It is nice to see fruits of the efforts to produce drugs in animal milk that started over 20 years ago.

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Coming from the process development side of the pharmaceutical industry I’m always interested in being able to efficiently model a process from the small scale to the large scale. A recent paper describes the researchers experience with scaling the drying process from a 200 g scale in a rotary evaporator (yes, than can be used for drying solids as well as stripping solvent) to a 1000 kg scale in three different types of driers.

Modeling the Scale-Up of Contact Drying Processes: Org. Process Res. Dev., 10 (3), 409 -416, 2006.

It should be noted that the model is not universal; only 5 of the 8 systems investigated worked. It also should be pointed out that there is still quite a bit of unpredictability. If, during the evaporation, the material forms one large lump (not an uncommon occurrence) then the model doesn’t work. The two other cases that failed were also due to aggregation during the drying process. While this aggregation can be reduced by reducing the rotation speed, this also slows down the drying process and resulted in longer drying times.

While this paper outlines a useful approach, processes such as drying still depend very much on the product itself.

Technorati Tags: process development

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