Biotech company's and Pharmaceutical comapany's I however know alot about since I am a Pharm. Engineer. The reason for the high costs are a lot of factors. First off the major factor is the FDA, and in Europe th EU. These are governing agencys that apply rulles and regulations to drug company's, for those of you who are not aware.
This agency's have the absolute power to shut down, fine or even give the company a 483 like Schering plough a few years ago that almost made them bankrupt. These agency's require tons and tons of tests on batches, raw materials, and final product. And before a product can even get ok'd by the FDA it has to go through Years and years of accurate and proven testing with a satisfactory record to ensure quality and effectiveness with side effects noted. This is a process which starts with an idea and eventually gets tested on human subjects for the final study's.
Now once the product gets approved for use and manufacturing by the FDA there are also many many tests each individual batches have to go through in order to be released. For one ALL equipment, processes, utiliteis, etc HAVE to be validated and calibraited if ness. this for one takes a ton of work and lots of man power Each validation staudy has an IQ( installation Qualification), OP(operational qualification) and PQ(performance Qualification) documents to ensure correct operation and accurate testing/ or operation. Once this is done there is a "start up" the validation process can last for up to 3 yrs sometimes preparing for manufacuting of the substance. This in itself requires lots of man hours and in turn lots of money. Anyway bla bla bla once the product is manufactured and all samples of raw materials have been qualified bla bla bla, these lots are put into bulk hold or quarantene, and random samples are atained throughout the bulk lot. All or subject to tons of tests. once all test results are complete accurate and meet acceptance criteria the lot is then moved out for hospitals or clinics or a warehouse awaiting shipment.
Now remember all of this documentation from the initial human testing to the Validation before start up to the final testing of the bulk product will be evaluated by the FDA. IF the FDA see's that during the process of manufacturing a bioreacot or hold tank or even a scale or bulk blender had not been validated during that time the WHOLE batch can be voided and recalled, this would mena the company would lose millions perspectively. Also all personal involved with the manufacture or anything involved with it has to be trained on the proper SOP's accociated with that process, if not again the company will probobly be fined but the product not ness. voided.
In addition these company's are producing mega amounts of product with some lab's clean rooms dedicated to the production of one drug some not. So these companies have what we call "clean rooms" whic can range anywhere from 100,000ppb to 10,000ppb and so on. This is the amount of particles in the air inside these rooms to ansure sterility. just to give you an idea in one breath of air you take there are milliions of air particles so you can imagine what it takes to get a room at 10,000ppb. Again this is required by the FDA.
Bottom line is REAL pharma companies spend millions of dollars on this process and also marketing and staff/ distibution. This is why the larger price for the products.
I infact still hombrew and have not had a problem with it but I tend to go to extremes with how I do it. NO one even a lab like GTP can ensure you with the sterility or tests to prove it like a real company such are Schering or Organon etc.