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IBT Bioservices Capabilities
- 1. A division of Discovery & Proof of Concept Capabilities at
- 2. Private company Discovery based R&D ~$40M in NIH, DOD development grants and contracts IBT Bioservices Testing services in vitro and in vivo for infectious disease research 35 clients served from virtual to large pharma 10,500 SF facility in Gaithersburg, Maryland, USA Dedicated animal rooms through partner 2 Founded 2005 R&D 2007 Bioservices 2009 Corporate Overview
- 3. Antiviral Testing Antibiotic Testing Animal Models Vaccine Testing Cytokines and Biomarkers Reagent and Assay Development 3 Service Areas S. aureus toxin-based vaccines and immunotherapeutics Filovirus vaccines and immunotherapeutics Internal Research
- 4. Trusted Expertise Collaboration / Communication Timely Execution and Results Cost Effective Process and Quality Standards Focus Discovery Stage Infectious Diseases 4 Value Generation
- 5. Cytotoxicity Cytopathic Effect (CPE) Virus Yield Reduction Classic plaque assay Immunoplaque assay TCID50 5 Antiviral Testing
- 6. 6 Antiviral Testing Chikungunya* Venezuelan Equine Encephalitis* Dengue 1 - 4 Japanese Encephalitis * Yellow Fever * Junin* H1N1 H3N2 Influenza B Rift Valley Fever* La Crosse Vaccinia RSV * BSL-2 Strains = low cost surrogates for BSL-3/4 viruses
- 7. Disc Diffusion Minimum Inhibitory Concentration (MIC) Minimum Bactericidal Concentration (MBC) Minimum Doubling Time/Growth Curve (MDT) 7 Antibiotic Testing
- 8. Methicillin-Sensitive S. aureus (MSSA) Methicillin-Resistant S. aureus (MRSA) Pseudomonas aeruginosa Acinetobacter baumannii Enterobacter aerogenes Enterobacter cloacae Streptococcus pneumoniae Moraxella catarrhalis Enterotoxigenic E. coli (ETEC) 8 Antibiotic Testing
- 9. Viral Infection Chikungunya Venezuelan Equine Encephalitis Dengue 2 Hemorrhagic Fever H1N1 H3N2 Influenza B Vaccinia Cowpox Japanese Encephalitis (in development) 9 Animal Models Areas of interest for future development Enteroviruses RSV Hantaviruses (Prospect Hill)
- 10. Dengue 2 Hemorrhagic Fever Strain: D2Y98P (DENV2) Mice: AG129 IP or SC Challenge (IP data shown) Low Challenge Dose Clinical Disease Progression Pro-Inflammatory Cyokines Vascular Permeability without Morphological Damage 10 Animal Models Tan GK, Ng JKW, et al. (2010) A Non Mouse-Adapted Dengue Virus Strain as a New Model of Severe Dengue Infection in AG129 Mice. PLoS Negl Trop Dis 4(4): e672 Tan GK, Ng JKW, et al. (2011) Subcutaneous Infection with Non-mouse Adapted Dengue Virus D2Y98P Strain Induces Systemic vascular Leakage in AG129 Mice. Ann Acad Med Singapore 2011; 40:523-32
- 11. Bacterial Infection Staphylococcus aureus Pneumonia Sepsis ETEC Streptococcus pneumoniae Staph/Strep Toxic Shock Areas of interest for future development: Pseudomonas aeruginosa Enterococcus faecalis Clostridium difficile 11 Animal Models S. aureus
- 12. Comprehensive Tissue Collection Spleen Lymph Nodes Bone Marrow Lung Liver Kidney GI, GU Tract Blood CFU / PFU determination in organs 12 Vaccine Testing Immunization Routes Intranasal Intragastric Subcutaneous Intramuscular Intraperitoneal Pathology and Immunohistochemistry through partner
- 13. Antibody Responses Serum/Plasma BAL Nasal Washes Vaginal Samples Fecal Samples Total Ab Titer Neutralizing Ab Titer OPK (currently established for S. aureus) 13 Vaccine Testing Vaccine Potency Immunogenicity in vivo Potency in vitro by competition assays, etc. 亮g/doseVLP Vaccine AntibodyUnits/mLSerum
- 14. Meso Scale Discovery (MSD) based assays Electrochemiluminescence Th1/Th2 Pro-Inflammatory Rodents or Human Multiplex 14 Capability MSD ELISA Capture capacity ~10^6 ~10^4 Dynamic range 3 - 4 logs 1 - 1.5 logs Sensitivity Sub-picogram Nanogram Sample volume 5 25 uL 50-100 uL Speed 3 hours ~6 hours Multiplex 10 analytes 1 analyte Cytokines and Biomarkers
- 15. 15 Reagent and Assay Development Reagent Sourcing / Qualification Optimization Best Practices for GLP Adaptation Assays PK Immunoassays Biomarkers Toxin Neutralization Virus Neutralization Serological Assays Immunogenicity Reagents Mouse mAbs Rabbit pAbs Recombinant Proteins Purification Characterization Quality Control
- 16. Antiviral Testing Antibiotic Testing Animal Models Vaccine Testing Cytokines and Biomarkers Reagent and Assay Development 16 Thank you for your time! services@ibtbioservices.com www.ibtbioservices.com Phone: +1 (877) 411-2041 Fax: +1 (240) 778-6805 Twitter: @IBT_Bioservices
Editor's Notes
- #2: Todd will thank group for the invitation and introduce Javad
- #3: ~25 people
- #4: Be prepared for a question about conflict of interest on this slide, but I wouldnt volunteer to discuss it.
- #5: Small project / subject matter groups allow us to limit bureaucratic delays. We add as much value as possible to our field of expertise as opposed to adding as many services as possible. Best of both worlds because we share academic curiosity with universities but rigors and repeatable tests of large CROs.
- #6: CPE is the first line screen for new compounds or new viruses because it is fast and inexpensive. Inhibitor controls are used where available.
- #7: PhD will manage and serve as point of contact
- #8: PhD will perform.
- #10: We will propose a measured approach so that $$ is used efficiently. i.e. basic tox, then mortality, then organ burden/cytokines or other readouts.
- #11: Previous DHF models could not replicate the virus well or had clinically irrelevant symptoms such as paralysis. SC challenge mimics a mosquito bite. Can provide papers on request.
- #15: Cover quickly, not our focus.
- #16: Cover quickly, not our focus. We are only cost effective for developing pathogen-related reagents that require our expertise.
- #17: Remind them to take a folder with our flyers.