The Bioanalytical Lab: Making Drug Development Possible

A casual visitor to the second floor of the year-old KU Clinical Research Center (KUCRC) might well wander by an important facility without being aware of its existence. There are no obvious signs and, as yet, it lacks a formal presence on the Internet. Here, however, is where certain processes fundamental to early drug development studies take place.

Known as the Clinical Pharmacology Bioanalytical Lab, this facility houses highly sensitive instruments designed to scrutinize samples of blood, other biological fluids or tissue treated with interesting new drugs. A drug's pharmacokinetics – how rapidly and efficiently it's absorbed and then eliminated from the body – are summarily revealed, providing clinical investigators with a wealth of information related to its effects, both therapeutic and adverse.

These methods of scrutiny have technical names, but it's not difficult to break down liquid chromatography and tandem-quadrapole mass spectrometry to their basics, says Greg Reed, Ph.D., member of the cancer center's Drug Discovery, Delivery and Experimental Therapeutics Program, and the facility's director.

"Splash some water on a piece of paper with writing," he says. "Legible pen marks quickly spread out into different colors. That's chromatography; the water is a solvent moving through the paper and separating chemicals in the ink, with the more water-soluble chemicals moving faster. Our liquid chromatography columns very reproducibly separate drug molecules from the rest of a sample for further analyses."

By further analyses, Reed means correctly identifying and quantifying drug molecules, which is where tandem-quadrupole mass spectrometry comes in – tandem as in two identical, linked instruments. Both work in sequence, with the first separating drug molecules by their molecular weight, and the second spectrometer breaking those molecules into smaller structures characteristic of the drug in question.

Think of a large mixed bag of M&M's, Dr. Reed suggests – plain, peanut and pretzel. "Say I want to find out how many red chocolate M&M's there are," he says. "I'll pour the whole bag into the first mass spectrometer and set it to pick out only red-colored candy, dispensing with the rest. Then I need to break apart all the red M&M's to see which ones contain chocolate. That's the second mass spectrometer in action. It hits incoming drug molecules with electrical energy – like little molecular hammers – and breaks them into highly reproducible fragments that we can measure."

A similar facility is located in the Hemenway Life Sciences Innovation Center; there, Dr. Reed operates and teaches KU researchers interested in learning to use similar bioanalytical equipment. The biggest differences are that the KUCRC-based Bioanalytical Lab has newer, more sensitive instruments and is fully compliant with GLP (good laboratory practice) standards – set by the Food and Drug Administration as the norm for the pharmaceutical industry, but somewhat rarer at academic medical centers.

"My staff and I are the sole operators of a dedicated bioanalytical service lab," he explains, "which enables us to meet the FDA's additional regulations governing GLP compliance."

Pharmaceutical companies are increasingly contracting out their bioanalytical work to specialized GLP-compliant labs. Dr. Reed hopes that the effort he's put into setting up a dedicated facility will help bring some of that business to KU. Given its newness and location, he's also working to improve awareness of the Bioanalytical Lab's services within KU; he was a recent cancer center grand rounds speaker and is scheduled to give several more talks targeted at clinicians in coming weeks.

"I'd like clinical investigators to know that we can add real value and strength to their studies, especially if we're involved in experimental design," he says. "While I can tell you with absolute certainty that the drug concentrations I report to you are accurate, that's based on what I was handed in the lab. If those samples weren't acquired at the right times relative to drug administration, or if they weren't processed or stored properly, then my measurements may not accurately reflect the drug's actual kinetics in the subject."

Dr. Reed would also like to change the tendency of clinical investigators to contract the bioanalytical aspects of their studies to organizations outside of KU. "We can do the actual analyses equally well and probably faster, while interacting more with investigators," he says. "Instead of just dosing subjects, collecting samples and then letting an outside entity tell you what it all means, why not work with us in analyzing and drawing conclusions about your own data?"

Ultimately, Dr. Reed wants to generate enough studies so the Bioanalytical Lab can be a full-time service facility for everyone – investigators at the KUCRC, the cancer center and the University of Kansas Medical Center. "To paraphrase the movie Field of Dreams," he says, "it's not 'If you build it, they will come,' but rather 'We have built it – will you come?'"

For more information on the Bioanalytical Lab at the KUCRC, contact Greg Reed, Ph.D., at greed@kumc.edu.


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