Development of a Cell Based Functional Assay to Be Presented by the FDA at Sample Prep East in Boston, MA, December 9-10, 2013

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Industry leaders from around the world will convene in Boston, MA for Sample Prep East conference which will take place at the Hyatt Regency Cambridge December 9-10 2013. One of the many anticipated presentations will include Shashi K. Sharma, a Research Microbiologist at the U.S. Food and Drug Administration, he presents “Development of a Cell Based Functional Assay for the Detection of Botulinum Neurotoxin Type A & E.”

Featured Abstract:
Shashi K. Sharma, Research Microbiologist, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration
“Development of a Cell Based Functional Assay for the Detection of Botulinum Neurotoxin Type A & E”

The standard procedure for definitive detection of BoNT-producing Clostridia is a culture method combined with neurotoxin detection using a standard mouse bioassay. The mouse bioassay is highly sensitive and specific, but it is expensive and time-consuming and there are ethical concerns due to use of laboratory animals. Cell based assays provide an alternative for mouse bioassay in screening for BoNT-producing Clostridia. Here, we describe a cell-based assay utilizing a fluorescence reporter construct with full length SNAP-25 as the linker, expressed in a neuronal cell model to study toxin activity in situ. Our data indicates that PC-12 cells have significant sensitivity to BoNT/A and E action and the assay can detect as little as 100 pM BoNT/A activity within living cells. Of the in vitro approaches published in the literature for BoNT detection, we believed that cell-based methods provide a model that more closely approximates the in vivo model and have a potential to at least reduce and refine animal assays if not replace it.

Sample Prep Conference Overview:
SAMPLE PREP EAST Conference is the 8th meeting in the Knowledge Foundation’s Sample Prep Conference Series - an internationally recognized meeting for experts in sample preparation technologies for detection, identification, diagnostics and analysis of biomedical, biological and chemical agents, substances and threats in point-of-care, laboratory and field settings will explore the latest R&D developments, ready-to-market technologies, and their applications by exploring the following topical areas:

  • Robust methodologies for sample collection, (pre-)concentration, lysis, and target extraction
  • Critical role of sample prep in early diagnostics
  • Rapid sample-to-sequence techniques
  • Point-of-care sampling, detection and analysis
  • Sample preparation with microfluidics
  • Sample prep-on-a-chip
  • Robust sampling methodologies (automation, high-throughput, combinatorial approach in sample prep)
  • Alternative amplification techniques for sensitive sample prep
  • Sample preparation as a separate system vs. an integrated module approach
  • End-user prospective for biodetection and sampling technologies and devices
  • Alternative and disruptive approaches to sample preparation and applications
  • Field-ready devices: compatibility/reliability/scalability

Sample Prep is Organized by the Knowledge Foundation
The Knowledge Foundation integrates scientific ingenuity and real-world applications by fostering collaborative research at the rapidly changing intersection of science and business. Known for providing members of its Technology Commercialization Alliance with direct and unbiased state-of-the-art scientific information, the Knowledge Foundation is uniquely qualified to provide wider exposure for important developments in the emerging fields of alternative energy, nanotechnology, and chemical & biological detection technologies.

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Craig Wohlers
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Matt DiCecca
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