That sound you can hear is sound of bioconservatives gnashing their teeth in horror: COSMOS Magazine has a decent long piece on transgenic animals and the role they may play in tomorrow’s pharmacology:
The greatest impact biopharming will have on the world’s medicine cabinet is one of supply – it will dramatically boost the availability of biopharmaceuticals, also known as ‘biologics’. Biologics are defined as medicinal products extracted from or produced by biological systems – many are made by genetically manipulating cells of bacterial, animal or human origin.
The majority of biologics are proteins such as hormones, enzymes, growth factors and antibodies, which can be collectively called therapeutic proteins, as well as viral proteins for use in vaccines.
This method of drug manufacture will make things cheaper… but not to the degree that you might expect:
A review of the scientific literature shows that a slew of antibody-based drugs manufactured in transgenic animals are poised to enter the market as soon as their branded competitors’ patents expire.
Traditionally, this would result in the transgenic animal-manufactured drugs being labelled as generic drugs – a non-patented, cheaper alternative to brand-name medications with the same active ingredient.
But because the antibodies that the transgenic animals produce are extremely complex monoclonal antibodies – large protein-based structures that specifically recognise one part of a target molecule – no two are alike. This means that, unlike the less complex ‘small molecule’ (non protein) structure of most drugs, they cannot technically be called generics.
“When GTC Biotherapeutics start marketing Herceptin from transgenic cows, it will be classed as a biosimilar, not a biogeneric. We may even end up having a better Herceptin, what we’d call a ‘biobetter’,” notes Heiden.
The ‘better’ refers to aspects of a drug’s profile that may be more desirable than those of its competitor, such as better efficacy or fewer side effects. These traits will affect pricing, but biosimilars will still be cheaper.
“The cost savings will be in the order of 30% – not the 80% price drops we see when a generic small molecule drug goes to market,” says Heiden. That’s because of where in the manufacturing process the savings impact. “Where we save money is at the front end. But the downstream cost of goods, which is about half of the total, is the same regardless of whether you are using cell culture or animals on a farm. You still have to extract and purify your product.”
Well, you do if you’re playing by the rules… I’ll bet there’s plenty of corners that can be cut if you’re not too bothered about meeting safety standards. Hmmm, the ideas for my genetic police procedural are all falling rapidly into place…