Monday, April 23, 2012

What are Biologics and How Are They Manufactured?

Biologics are medicinal products created by a biological process - as opposed to chemical synthesis. What this means is that you can't get a couple beakers, Petri dishes and Bunsen burners in a lab and produce drugs like growth hormone.

Say you wanted growth hormone before Watson and Crick discovered DNA. You'd have to squeeze growth hormone out of the pituitary glands of pigs. This sucked because after you've gone through all the trouble of a sterile preparation, you're still left with porcine growth hormone. Worse, the manufacturing process is unscalable.

Now that we know about DNA, the manufacturing of biologics at large-scale is possible.

botox You see, medicine these days - as in drugs - are often complex proteins.

Proteins are molecules - composed of a sequence of amino acids - whose shape is determined by the sequence of said amino acids.

Amino acid sequence is determined by the DNA sequence.

So if you want to make biologics, you basically have to start with the protein... reverse engineer the amino acid sequence and then string together DNA that encodes for the amino acid sequence.

If you transfect (i.e. poke your DNA into) CHO cells (or other mammalian cells) and the DNA lands on a part of the chromosome that gets high ribosome traffic, then you have a cell line capable of producing the active pharmaceutical ingredient (API).

Biologics manufacturing then becomes growing the cells/having them secrete the API (a.k.a. cell culture) and subsequently purifying the drug.

Biologics made with recombinant DNA technology can be made reliably. Lean manufacturing principles can be applied and significant medical needs can be met.

Companies that own the infrastructure to identify marketable proteins and manufacture tons of it (while meeting regulatory requirements) are the ones with dominant positions.

More on cell culture.

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