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High Potency

by Rudy Baum,
June 16, 2008 | APPEARED IN VOLUME 86, ISSUE 24

This week's cover stories by Senior Correspondent Ann Thayer are C&EN's annual feature on fine chemicals and intermediates. In the first of two stories, Thayer focuses on manufacture of highly potent compounds for pharmaceuticals; in the second story, she looks at an important subset of such compounds, conjugates of potent drugs and biological molecules.

As Thayer makes clear in her lead story, "Contained Chemicals," manufacturing highly potent active pharmaceutical ingredients (APIs)—ones that work at doses of less than 10 mg—is not for the faint of heart or the technically unsophisticated. Such compounds, especially those for treating cancer, are a growing proportion of drug development projects. Not surprisingly, therefore, an increasing number of contract chemistry firms are touting their high-potency-manufacturing capabilities. Whether all of them are up to the task is another question.

"There are contenders and there are pretenders," John P. Farris, president of SafeBridge Consultants, told Thayer. SafeBridge offers toxicology, industrial hygiene, and analytical services around potent compounds. The company has established a system for evaluating how companies should handle the manufacture of highly potent compounds safely.

"Farris and others in the industry say simply isolating a room and putting workers in protective suits doesn't qualify as containment," Thayer writes. "Instead, the process equipment must be contained so that there are no releases to the workroom when materials are transferred between vessels."

"And protective suits are only redundant, not primary, protection," Farris told Thayer. "Anything else is not acceptable. The contenders understand this."

Thayer surveys the efforts of many of those contenders in her story, the compounds they are manufacturing, and the facilities they are putting into place to do it. Because of the importance of highly potent APIs in pharmaceutical companies' futures, these capabilities will be important distinguishing features for successful fine and custom chemicals manufacturers.

In her second story, Thayer addresses the development of conjugates, molecules that combine a highly cytotoxic drug with a biological agent such as a monoclonal antibody to deliver the drug to a specific target such as a cancer cell. Although only one conjugate has made it to market so far, their promise has led numerous pharmaceutical companies to enter this area. For manufacturers, conjugates present the same challenges as high-potency APIs combined with the need to handle biological molecules and the sophisticated linkers needed to complete the conjugate. Again, the sophistication required to compete successfully in this market will give some firms a significant competitive advantage.

On a lighter note, C&EN Online's permanent blog, C&ENtral Science, has been in existence for more than two months. We launched C&ENtral Science on March 28, just prior to the ACS national meeting in New Orleans. While we haven't posted every day since then, we have averaged darned close to one post per day.

There's a wealth of sometimes quirky, sometimes offbeat, sometimes moving, sometimes controversial items on the C&ENtral Science that are not quite right for C&EN's print edition or C&EN Online itself. The writing style is breezy and conversational.

On many days, two of C&ENtral Science's stalwarts, Bethany Halford and Lisa Jarvis, post "Chemistry Newsbytes" a potpourri of links to stories involving chemistry from around the world. On May 20, for instance, the first three newsbytes were on "Homemade hooch is becoming hot high-end hobby" (Wired), "Or you could just learn how great beer is made" (NPR), and "On a healthier note, you should just eat your veggies. But is it better to cook them or eat them raw?" (New York Times).

Among the many items on C&ENtral Science are these editorials, along with the opportunity to provide instant feedback on them to me and the other readers of C&EN.

I hope you will spend a little time getting to know C&ENtral Science. It's a different side of C&EN.

Thanks for reading.

Views expressed on this page are those of the author and not necessarily those of ACS.



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