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Dec 1, 2006 (Vol. 26, No. 21)

Bioanalytical Systems Targets CRO Niche

Company Offers Applications from Mouse to Mammal

  • Peter Kissinger, Ph.D., started Bioanalytical Systems (BASi; www.bioanalytical.com) 32 years ago in his garage with just $365. He tinkered on his inventions in his spare time, as all researchers had to do before SBIR grants.

    Dr. Kissinger successfully created scientific instruments to monitor tiny amounts of chemical substances such as neurotransmitters. “We identified markets where people working in biological areas, like psychiatry, neuroscience, and drug metabolism, needed to make accurate chemical measurements,” says Dr. Kissinger, CEO at BASi in West Lafayette, IN.

    The first instruments combined liquid chromatography and electrochemical devices to detect dopamine, serotonin, and other chemicals associated with depression, schizophrenia, and Parkinson’s and Alzheimer’s disease. At first, academic researchers bought the specialized instruments, then pharmaceutical companies interested in finding new drugs for central nervous system disorders began buying the instruments.

    In the late 1980s, some pharmaceutical customers asked BASi’s application chemists to develop bioanalytical methods specifically for them and then to process the biological samples they were collecting. “This was the early stage of our bioanalytical outsourcing,” says Dr. Kissinger. Now contract research work accounts for three-quarters of BASi’s business.

    Peter Kissinger, Ph.D., started Bioanalytical Systems (BASi; www.analytical.com) 32 years ago in his garage with just $365. He tinkered on his inventions in his spare time, as all researchers had to do before SBIR grants.

    Dr. Kissinger successfully created scientific instruments to monitor tiny amounts of chemical substances such as neurotransmitters. “We identified markets where people working in biological areas, like psychiatry, neuroscience, and drug metabolism, needed to make accurate chemical measurements,” says Dr. Kissinger, CEO at BASi in West Lafayette, IN.

    The first instruments combined liquid chromatography and electrochemical devices to detect dopamine, serotonin, and other chemicals associated with depression, schizophrenia, and Parkinson’s and Alzheimer’s disease. At first, academic researchers bought the specialized instruments, then pharmaceutical companies interested in finding new drugs for central nervous system disorders began buying the instruments.

    In the late 1980s, some pharmaceutical customers asked BASi’s application chemists to develop bioanalytical methods specifically for them and then to process the biological samples they were collecting. “This was the early stage of our bioanalytical outsourcing,” says Dr. Kissinger. Now contract research work accounts for three-quarters of BASi’s business.

    Peter Kissinger, Ph.D., started Bioanalytical Systems (BASi; www.analytical.com) 32 years ago in his garage with just $365. He tinkered on his inventions in his spare time, as all researchers had to do before SBIR grants.

    Dr. Kissinger successfully created scientific instruments to monitor tiny amounts of chemical substances such as neurotransmitters. “We identified markets where people working in biological areas, like psychiatry, neuroscience, and drug metabolism, needed to make accurate chemical measurements,” says Dr. Kissinger, CEO at BASi in West Lafayette, IN.

    The first instruments combined liquid chromatography and electrochemical devices to detect dopamine, serotonin, and other chemicals associated with depression, schizophrenia, and Parkinson’s and Alzheimer’s disease. At first, academic researchers bought the specialized instruments, then pharmaceutical companies interested in finding new drugs for central nervous system disorders began buying the instruments.

    In the late 1980s, some pharmaceutical customers asked BASi’s application chemists to develop bioanalytical methods specifically for them and then to process the biological samples they were collecting. “This was the early stage of our bioanalytical outsourcing,” says Dr. Kissinger. Now contract research work accounts for three-quarters of BASi’s business.

    Peter Kissinger, Ph.D., started Bioanalytical Systems (BASi; www.analytical.com) 32 years ago in his garage with just $365. He tinkered on his inventions in his spare time, as all researchers had to do before SBIR grants.

    Dr. Kissinger successfully created scientific instruments to monitor tiny amounts of chemical substances such as neurotransmitters. “We identified markets where people working in biological areas, like psychiatry, neuroscience, and drug metabolism, needed to make accurate chemical measurements,” says Dr. Kissinger, CEO at BASi in West Lafayette, IN.

    The first instruments combined liquid chromatography and electrochemical devices to detect dopamine, serotonin, and other chemicals associated with depression, schizophrenia, and Parkinson’s and Alzheimer’s disease. At first, academic researchers bought the specialized instruments, then pharmaceutical companies interested in finding new drugs for central nervous system disorders began buying the instruments.

    In the late 1980s, some pharmaceutical customers asked BASi’s application chemists to develop bioanalytical methods specifically for them and then to process the biological samples they were collecting. “This was the early stage of our bioanalytical outsourcing,” says Dr. Kissinger. Now contract research work accounts for three-quarters of BASi’s business.

  • Contract Research

    Today, the company’s contract research services operate out of five laboratories covering 300,000 sq-ft. Bioanalytical laboratories are located in West Lafayette, McMinnville, OR, and Warwickshire, U.K. A toxicology laboratory is located near Evansville, IN, and a clinical research unit is in Baltimore.

    At these facilities, BASi offers an array of laboratory services, including pharmaceutical product stability testing, preclinical pharmacology and toxicology, and bioanalytical mass spectrometry. “We’re known for our bioanalytical expertise in processing samples from clinical trials worldwide,” says Dr. Kissinger.

    In addition, BASi conducts Phase I trials at its clinical unit in Baltimore and it partners with other CROs on genomics, toxicology, and proteomics projects. BASi also continues to manufacture specialized instruments for both analytical chemistry and in vivo pharmacology.

    Researchers involved in drug metabolism, pharmacokinetics, pharmacodynamics, safety pharmacology, and pharmaceutical product analysis use BASi’s products and services, according to Dr. Kissinger. Most of the world’s top pharmaceutical and biotechnology companies have used BASi’s services or products to develop some of the leading drugs now approved for HIV, schizophrenia, depression, erectile dysfunction, pain, cancer, infectious diseases, and diabetes, he adds. “It’s nice to see millions of patients being helped by drugs that we have contributed to.”

  • Preclinical Services

    After starting out by manufacturing bioanalytical instruments, then moving into processing samples on a contract basis, BASi decided to move farther upstream by setting up preclinical toxicology and pharmacology services. Researchers at many biotechnology companies concentrate on discovery biology, using in vitro and in silico tools to isolate cell receptors or other drug targets.

    The staff at BASi confirms the safety and effectiveness of these discoveries in order to obtain FDA approval. “Our business focuses on obtaining data in order to file INDs and NDAs with the FDA,” says Dr. Kissinger, adding, “we’re the ‘D’ part of R&D.”

    Just five years ago, the majority of BASi’s clients were among the top-20 pharmaceutical companies. However, in an emerging trend, smaller discovery companies are using BASi’s contract research services. “They are hanging on to their technologies longer before licensing them to big pharma,” notes Dr. Kissinger. Compared to the 1990s, big pharma also wants to invest in more advanced projects with supporting INDs and Phase II trial results. “They want projects with a higher probability of success that will advance to market, and they are willing to pay a great deal to get them,” he says.

  • Combinatorial Pharmacology

    One of the company’s main product lines, Culex® (www.culex.net), is particularly designed for preclinical development. This automated pharmacology system establishes pharmacokinetic profiles of drugs during early screening in rodents quickly and cost effectively. Rather than using many individual animals for different pharmacokinetic/ pharmcodynamic experiments, Dr. Kissinger reports that the Culex technology obtains combinatorial streams of information from the same animal over periods ranging from hours to day.

    For instance, a drug can be injected into a single animal, then physiological measures, such as heart rate and blood pressure, behavior measures, biomarkers, and pharmacokinetics can be explored without touching the animal. This approach, called combinatorial pharmacology, minimizes the number of laboratory animals needed and maximizes the stream of data collected.

    “Combinatorial pharmacology allows researchers to correlate chemical information with physiological and behavioral information in the same animal,” says Dr. Kissinger, “giving data that are much tighter than traditional approaches.”

    The Culex system, a set of coordinated instruments, programs dosing via various routes; samples blood in quantities of 5 to 2,000 microliters; dispenses blood into sealed and refrigerated vials; returns sterile saline to animals to compensate for blood loss; collects bile and urine in chilled vials; and collects feces separately.

    Proprietary software controls each sampling method for up to four individual animals. The Culex product line includes microdialysis sampling devices, infusion pumps, behavior monitors, and metabolism cages that are designed to prevent the trauma of touching and manipulating animals. Laboratory animals are fitted with automated dosing and sampling devices that allow them to move freely while data are collected. Handling animals to inject drugs or draw blood from a tail vein stresses rodents, resulting in highly distorted data, Dr. Kissinger maintains.

    The Culex system is installed at a number of large and small pharmaceutical companies. BASi offers the same service on a contract research basis at its in-house vivarium.

    “It’s the only one in the world, outside of pharmaceutical companies, that can perform this complex pharmacology,” boasts Dr. Kissinger. By reaching conclusions faster with Culex products, researchers can decide whether to drop a project early to save money or to continue to fund a worthy project. By validating the safety and efficacy of in vitro and in silico discoveries in whole animals, BASi’s goal is to help move new drugs to market more rapidly. Dr. Kissinger calls his company a “mouse-to-man operation,” because “a mammal is more than the sum of its parts.”



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