INFO - How biologics are made

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FTC

Commissioner Pamela Harbour

14 Jun 2007

" The Competitive Implications of Generic Biologics "

Excerpt:

In simplest terms, biologics are drugs created from living cells,

tissues, or organisms,

through biologic processes. These drugs replicate natural biologic

substances in our bodies, such

as enzymes, antibodies, or hormones. Biologics are known as “large

molecule” drugs, which

means they typically are very complex in structure.

Many of today’s " miracle " drugs are biologics. These drugs are used to

treat cancer,

immune disorders, and metabolic diseases. They drastically reduce

disabling symptoms, and

sometimes even save lives.

Biologics require extremely sophisticated manufacturing techniques. Biologics

manufacturers must program a living source to mass-produce a specific

biological material. For

example, scientists may use recombinant DNA technology to program

instructions directly into

the DNA of a cell. The cell will produce the desired protein, which

can be harvested and used

as a therapeutic drug or a diagnostic product.

In contrast, traditional pharmaceutical drugs are " small molecule "

compounds that are

chemically synthesized, and usually consist of pure chemical

substances. They are easier to

manufacture, and they are also easier to analyze after they are manufactured.

http://www.ftc.gov/speeches/harbour/070614genbio.pdf

Not an MD