Upload
todd-pelham
View
115
Download
5
Tags:
Embed Size (px)
Citation preview
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
Founded2005
R&D2007
Bioservices
2009
Corporate Overview
3
Antiviral Testing
Antibiotic Testing
Animal Models
Vaccine Testing
Cytokines and Biomarkers
Reagent and Assay Development
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
Value Generation
5
Cytotoxicity
Cytopathic Effect (CPE)
Virus Yield Reduction Classic plaque assay Immunoplaque assay TCID50
Antiviral Testing
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)
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)
Antibiotic Testing
9
Viral Infection
Chikungunya
Venezuelan Equine Encephalitis
Dengue 2 Hemorrhagic Fever
H1N1
H3N2
Influenza B
Vaccinia
Cowpox
Japanese Encephalitis (in development)
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
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
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
Vaccine Testing
Immunization Routes Intranasal Intragastric Subcutaneous Intramuscular Intraperitoneal
Pathology and Immunohistochemistry through partner
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.
μg/doseVLP Vaccine
Anti
body U
nit
s/m
L Seru
m
14
Meso Scale Discovery ™ (MSD) based assays Electrochemiluminescence Th1/Th2 Pro-Inflammatory Rodents or Human Multiplex
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
Reagent and Assay Development
Reagent Sourcing /
QualificationOptimization
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
Thank you for your time!
www.ibtbioservices.com
Phone: +1 (877) 411-2041
Fax: +1 (240) 778-6805
Twitter: @IBT_Bioservices