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September 2015 - Issue 3
Welcome to Battelle’s Life Sciences Research CRO+ Today Newsletter. The Battelle Life Sciences Research team provides fast, accurate answers for discovery, safety and efficacy with our integrated scientific and technological capabilities, world-class facilities and ability to meet technical, development and regulatory needs. Battelle Life Sciences CRO+ Today will keep you up-to-date on cutting-edge life sciences research.
There are approximately 200 chemicals with known toxic effects on the brain and nervous system—but the neurotoxic potential of thousands of substances and chemicals to which we are regularly exposed remains largely unknown or poorly understood. The importance of neurotoxicity and developmental neurotoxicity testing is increasing as regulatory agencies try to fill data gaps where critical toxicity information may be lacking. Battelle is expanding their neurobehavioral testing capabilities to support critical research on the neurological effects of drugs, occupational chemicals, pesticides and other substances.
Nervous system toxicity may have serious and permanent effects on neurological function and behavior. The developing nervous system in particular is more sensitive to damage than the adult nervous system. Early injury can have long-lasting or even permanent functional or behavioral consequences that negatively impact the individual, families and society.
The incidence of several childhood developmental disorders is on the rise; the CDC estimates that nearly 1 in 6 children have a developmental disability such as ADHD, learning disabilities, autism spectrum disorder, cerebral palsy or developmental delays. At the same time, both children and adults are now exposed to an unprecedented number of drugs, pesticides, and other chemicals—many of which have not been fully studied for neurotoxic effects. While it is currently unknown whether these phenomena are linked, developmental neurotoxicity testing could shed new light on the rising incidence of developmental disorders.
With increasing need for evaluation of exposure to the developing nervous system, Battelle is committed to building world-class expertise in behavioral and developmental neurotoxicology to help clients solve their challenging problems. The assessment of neurotoxicity and developmental neurotoxicity requires sophisticated testing capabilities and scientific expertise to uncover relevant, but often subtle, effects on the nervous system. To rise to the challenge, Battelle has recruited staff with subject expertise in neurotoxicology and neurobehavior and invested in a complete array of neurobehavioral equipment for all levels of CNS testing. Battelle’s neurotoxicity and neurobehavioral testing capabilities were designed with flexibility and throughput in mind and to operate under Good Laboratory Procedure (GLP) conditions to fulfill ICH, OECD and OPPTS guidelines.
Highlights of Battelle’s testing capacity include Tier I functional observational tests in multiple species and more sophisticated Tier II testing including locomotor activity and startle response/pre-pulse inhibition testing, motor coordination and sophisticated gait analysis using the DigiGate imagine device, learning and memory assessment, elevated plus maze. These tests can be conducted over multiple age ranges with most having high throughput capability. Battelle also offers sophisticated neuropathological evaluation including special staining and offers combined protocols with EEG and blood pressure/heart rate analysis with simultaneous behavioral monitoring capability.
In the coming months Battelle scientists will elaborate on some of these exciting capabilities and will provide a more in-depth examination into the unique capabilities and sophisticated application of these techniques.
Battelle offers a complete package of central nervous system (CNS) testing for safety pharmacology, drug development and environmental industrial- and agro-chemicals.
There is a lack of data for how the viability of biological agents may degrade over time in different environments. In this study, experiments were conducted to determine the persistence ofBacillus anthracis and Bacillus subtilis spores on outdoor materials with and without exposure to simulated sunlight, using ultraviolet (UV)-A/B radiation.
Spores were inoculated onto glass, wood, concrete, and topsoil and recovered after periods of 2, 14, 28, and 56 days. Recovery and inactivation kinetics for the two species were assessed for each surface material and UV exposure condition. Results suggest that with exposure to UV, decay of spore viability for both Bacillus species occurs in two phases, with an initial rapid decay, followed by a slower inactivation period. The exception was with topsoil, in which there was minimal loss of spore viability in soil over 56 days, with or without UV exposure.
The greatest loss in viable spore recovery occurred on glass with UV exposure, with nearly a four log10 reduction after just two days. In most cases, B. subtilis had a slower rate of decay than B. anthracis, although less B. subtilis was recovered initially.
Liquid chromatography-tandem mass spectrometry (LC–MS/MS) has been widely utilized for the analysis of compounds in biological matrices due to its selectivity and sensitivity. This study describes the application of an LC–MS/MS-based approach toward the analysis of cobinamide in Yorkshire pig plasma. The selectivity, accuracy, precision, recovery, linearity, range, carryover, sensitivity, matrix effect, interference, stability, reproducibility, and ruggedness of the method were investigated in pig plasma.
The accuracy and precision of the method was determined to be within 10% over three different days over a range of concentrations (25–10,000 ng/mL) that spanned more than two orders of magnitude. The lower limit of quantitation (LLOQ) for dicyanocobinamide was determined to be 25 ng/mL in pig plasma. Carryover was acceptable, as the area response of the carryover blanks were ≤15% of the area response of the nearest LLOQ standard for the analyte, while it was nonexistent for the internal standard. Specificity was ensured using six different lots of pig plasma. While the matrix effects of dicyanocobinamide in plasma were enhanced, ginsenoside Rb1 experienced signal suppression under the described conditions.
The absolute recovery results for both compounds were consistent, precise, and reproducibly lower than expected at ∼60% for dicyanocobinamide and ∼22% for ginsenoside Rb1, confirming that a matrix standard curve was required for accurate quantitation. Cobinamide was shown to be very stable in matrix at various storage conditions including room temperature, refrigerated, and frozen at time intervals of 20 h, 4 days, and 60 days respectively.
This method was demonstrated to be sensitive, reproducible, stable, and rugged, and it should be applicable to the analysis of cobinamide in other biological matrices and species.
Battelle is proud to announce that four of our staff scientists--Joshua Johnson, Richard Bennett, Krisztina Janosko, and James Pettitt —were selected by Francis S. Collins, M.D., Ph.D. on November 17, 2015 to receive a 2015 NIH Director’s Award for their exceptional dedication in providing overseas support of Ebola diagnostic efforts in West Africa.
These scientists support the Integrated Research Facility (IRF) as part of the National Interagency Biodefense Campus, a group of federal biomedical research facilities based at Fort Detrick, Maryland. They focus on developing prevention and treatment options that will be directly relevant to human diseases—whether they emerge naturally or are deliberately introduced.
The BSL-4 capabilities, techniques and knowledge that they have gained have translated into providing outbreak support around the world. Field work/deployments have included: Cameroon to provide response to a suspected and later confirmed orthopox outbreak at a Chimpanzee Preserve, Mongolia to provide diagnostic support in suspected MERS outbreak in camels, and Sierra Leone and Liberia to provide diagnostic support for the Ebola outbreak.
Eve Mylchreest brings deep expertise in the area of developmental and reproductive toxicology (DART) that is invaluable to our government, industrial and pharmaceutical clients. In her role as Research Leader, she is focused on expanding Battelle’s capabilities in these areas.
Dr. Yun Li joined the Battelle Life Sciences Research Team this past summer. As a Principal Scientist, she will be putting her experience in virology and microbiology to work to develop new bioassays and conduct efficacy studies of novel drugs and vaccines.
Battelle is pleased to welcome Dr. Amy Zmarowski to the Life Science Research team as a Principal Research Scientist. Amy brings extensive experience in developmental neurotoxicology and developmental and reproductive toxicology. In her new role, she will be helping to expand Battelle’s neurobehavioral capabilities for non-clinical toxicology and safety assessment.