IBT Bioservices Capabilities

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!

services@ibtbioservices.com

www.ibtbioservices.com

Phone: +1 (877) 411-2041

Fax: +1 (240) 778-6805

Twitter: @IBT_Bioservices