Minneapolis patent attorney Jim Nelson of Schwegman, Lundberg & Woessner differentiates biologics from small molecules.
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All right. So we talked about how biologicals are different from small molecules. And small molecules, as the name indicates, they’re small and they’re easy to produce. Chemists are able to synthesize them without the help of living tissue, of living cells. And they run chemical reactions. And so once the chemist has the product, the chemist is able to analyze the product and demonstrate it’s 100-percent pure. No other impurities in the product. Great stuff. The biological, of course, is very large. It’s a peptide. It may be 200 amino acids long, 2,000 amino acids long, 10,000 amino acids long. It’s a very, very large molecule. And because it’s produced by living cells, you’re never gonna have it 100-percent pure. It always comes with other stuff, other stuff that the cells have produced.
So just like the wine production from the Rutherford Winery where grapes from one ten-square-foot plot produce a wine that doesn’t taste anything like the wine from another ten-square-foot plot right close by. Because of the air, the rain, the soil, the soil content, the bugs that are attacking the grapevines, all those things, you’re gonna get this large variety of taste and mouth feel and aroma in the wine. So there’s a very broad variation in the wine from one year to another and from one plot to another for the same year. Same is true for the biologicals. There’s a very large variation from one batch to another and from one production factory to another because of all that other stuff that these living cells produce.
As you know, when you make wine, you press the grapes, you get the grape juice, then you put ’em in a vat and you ferment it. What’s going on in fermentation? Oh, well, they’re living cells, yeast cells that go in and ferment the sugar, convert it to alcohol, and they do all kinds of other things, and it produces this very complex mixture of ingredients that we all love as wine. Same is true for the biologicals. You take this DNA, this information, you put it into the cell, and then you put the cell in a vat, and then basically, what you’re doing is you’re fermenting these cells and they’re producing this peptide, but they’re doing all kinds of other things too. And the juice that you get out, it contains that peptide, but it – that polypeptide, but it is in mixture with all kinds of other things. That’s why the biologicals are so different. They are complex, whereas the small molecules, the pharmaceuticals like Lipitor that you take, it’s one molecule, it’s the same thing every time batch to batch, everybody can produce the same thing 100-percent pure.