Minneapolis patent attorney Jim Nelson of Schwegman, Lundberg & Woessner defines Merrifield Synthesis.
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Well, interesting, Merrifield Synthesis is a chemistry way to produce proteins. As I said before, a biological product is a protein. It’s a polypeptide. It’s a long chain of certain kinds of amino acids all stuck together. There are many 200 of ’em in the chain. There may be 2,000 of them in the chain. There may be 10,000 of them in the chain. As you get larger and larger, of course, it’s more difficult to produce the same thing. Well, the Merrifield Synthesis is a chemical way of putting these little amino acids together into a long chain of polypeptides. That’s a chemical synthesis, so it would be much like the way that chemists use to produce Atorvastatin, Lipitor. That’s not what a biological is, however. Biological is typically produced with living cells. In other words, the biochemist develops DNA. And everybody knows what DNA is these days. It’s the information, it’s the code that tells a living organism, a cell, how to make the protein. And so biochemists are able to develop a particular code, the DNA, to put into cells like E.coli, single cells, or more complicated cells from hamsters, for example, hamster ovary cells, CHO cells they’re called.
Anyway, you are able to insert this code into the cell and then the cell goes through its mechanism and it translates that code and it produces a peptide. So that kind of production is a biological production, and it is more difficult and filled with more error than the Merrifield Synthesis. The Merrifield Synthesis is on the laboratory bench, it doesn’t involve living cells, the cells aren’t producing other things. Well, the Merrifield Synthesis doesn’t produce other things, whereas the cells, the E.coli cell, the simple cell, all the way up to mammalian cells, they produce other things. They’re living. And so in addition to what you want, you all kinds of junk. And therein is the problem with biologicals. Like I alluded to with wine, the biologicals, each batch is gonna be unique to some degree because of all the other stuff that these cells are producing. So the biological production is not like a Merrifield Synthesis. It’s not like a chemical synthesis. It’s more like the production of wine.