Crisis intervention, and ensuring drug quality for all consumers

Many remember when—in the spring of 2008—a contaminated blood thinner made in China led to the deaths of eighty-one people in the United States.

The tainted samples of the drug, known as heparin, also sickened hundreds of others. For health officials, the casualties served as a tragic wake-up call: More than ever, in an age of international production, drugs require rigorous testing before they’re given to patients. Careful regulation has become, quite literally, a matter of life and death.

Today, Northeastern’s Barnett Institute of Chemical and Biological Analysis is responding to this need with its Center for Advanced Regulatory Analysis, which will allow it to play a critical role in ensuring drug quality for all consumers.

This venture is just the latest example of the Barnett Institute’s leadership in the realm of chemical analysis. During its thirty-seven-year history, the research powerhouse has pioneered breakthroughs in forensic science, advanced materials study, and biotechnology.

The Center for Advanced Regulatory Analysis is developing first-rate drug-analysis methods by working with companies to produce new instruments for use in regulatory environments and by training scientists in the latest analysis techniques, explains Dr. Barry Karger, Director of the Barnett Institute.

The effort is expected to have a global impact.

“Obviously, we have a crisis looming in determining the composition of biological agents used as drugs,” says Barnett associate director Graham Jones, professor and chair of chemistry and chemical biology.

“The heparin crisis was huge,” Jones says. “There’s a need for independent oversight and for good advice for would-be drug manufacturers. And the Food and Drug Administration wants technologies that can detect problems in the composition of drugs before they become problems in the clinic.”

Many drugs and drug ingredients are produced in labs outside the United States, which number in the thousands. According to a 2007 U.S. Government Accountability Office report, international labs are inspected, on average, just once every thirteen years.

Recognizing the magnitude of the problem as well as its impact on world health, the U.S. Food and Drug Administration (FDA) recently announced it would hire 1,300 new professional staffers to help the agency strengthen its inspection of international facilities and better protect the public health.

But the drugs coming out of these labs will still need rigorous testing. Drugs made in the United States need scrutinizing as well, especially protein pharmaceuticals, which are used to treat cancer, diabetes, and hepatitis. By 2010, $20 billion worth of protein pharmaceuticals will be off patent, opening the door to companies seeking to make “biosimilar” versions.

What are biosimilars? New drugs often have complex structures derived from living organisms; making identical copies of them is difficult. So companies produce biosimilars, which aim to match the original drugs as closely as possible.

“The question is, how similar are they?” asks Karger. “Characterizing these complex products is a big challenge. That’s what we’re trying to work on.”