Ai Biotech Mktg Overview 0411

AI Biotecha scientific force

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CAPABILITIES OVERVIEW

Adam H. Libby, Ph.D.Business Development Manager

601 Biotech DrRichmond, VA 23235Phone: 804 385 3294Phone: 800 269 4822

Email: [email protected]


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Contract Research Laboratory

Integrated Project Support for Development and Manufacturing of

Biologics and Specialty Diagnostics

BiologicsBiologics SpecialtyDiagnostics

SpecialtyDiagnostics

AI BiotechBio MolecularTechnologies

AI BiotechBio MolecularTechnologies


A Focus on Early Stage Discovery and Development

TargetIdentification

pre-clinical testing clinical testing

client

CROs

Drug Candidates

AI Biotechnology Services


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AI BioTech is a Division of Bostwick Laboratories, Inc.

VirginiaVirginia FloridaFlorida

New New York York

United Kingdom (London)United Kingdom (London)

AIBioTech, VirginiaAIBioTech, Virginia


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AI BioTech, Richmond, VA

Staff 70 employees

70% scientists, Ph.Ds, M.S., B.S. 20 % Administration, IT, Sales and Marketing 10% Quality assurance and Regulatory Compliance

Clients Serviced over 5,500 clients in more than 2,500

institutions world-wide. >30% repeat clients 80% Commercial Organizations 5% Academic Centers 15% Government Institutions


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Facilities and QualityFacility Operations 32,000 sq ft and GLP Compliant BSL-3 laboratories for bacterial and viral agentsLICENSES, REGISTRATIONS, CERTIFICATIONS CLIA – Clinical Laboratory Improvement Act

Allows for testing of human samples CAP – College of American Pathologists

Certified clinical testing lab, licensed in all States (New York Pending) AABB – American Association of Blood Banks

Human genetics & genotyping ISO/IEC 17025:2205 FRA1 and FRA 2

Forensic DNA analysis NFSTC – National Forensic Science Technology Council

Forensic DNA analysis USDA – United States Department of Agriculture

Allows for testing of animal samples and handling plant & animal pathogens NRC – Nuclear Regulatory Commission

Radioisotope use DEA – Drug Enforcement Agency

Class 1 – 6 controlled substances CDC Select Agent Registration

Allows for handling of bio-threat organisms & toxins


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Strengths Broad Ranging Expertise

scientists with a broad range of expertise and practical experience in an array of disciplines.

Breadth of Technologies state-of-the-art technologies, providing a range of options to solve almost any problem.

A Collaborative Culture a stimulating, open environment where scientists collaborate among themselves and with

our clients, taking on interesting challenges and developing creative solutions


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Key Differentiators Focus exclusively on laboratory services Customized assays along the drug development

continuum Specialize in Biologics / Bio-Pharmaceuticals Flexible Outsourcing Model

Extension of Your Lab to fill in capacity Consultative and collaborative for special expertise

Direct access to scientists Senior scientists develop SOW and project fulfillment


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AI BioTech is a GLP Facility

Operates under Good Laboratory Practices (GLP) Guidelines (21 CFR 58).

Approved Laboratory Quality Assurance Plan

Approximately 500 SOPs in Support of Our Broad Technology Base


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Core Enabling Technologies


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Core Laboratory Functions Protein Chemistry Bioanalytics Bioorganic Chemistry Nucleic Acid Chemistry Immunochemistry Microbiology Recombinants and Over Expression DNA Reference Lab Clinical Trial Support Services Clinical Testing Services


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Protein Chemistry Proteomics

Proteome maps from 2-D gels and other systems Isolate and characterize protein Bioinformatics

Protein analysis, mapping, and sequencing Chromatographic mappping Mass spectral analysis and mapping by MALDI-TOF/MS, LC/MS, Mass spec sequence analysis by MSMS, automated Edman degradation. C terminal sequence analysis Amino acid analysis Chromatographies Electrophoresis


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Bioanalytics

Calorimetry (ITC, DSC) Spectroscopies (CD, Fluorescence, UV/Vis,

Light Scattering) Mass spectrometries (MALDI-TOF/MS, Q Tof

LC/MS, Q Trap Triple Quad LC/MS) GC/MS HPLC


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Bioorganic Chemistry

Design and Optimization of Synthesis routes Milligram to hundred gram scale Pharmacophores, Inhibitors, Substrates, Carrier

molecules


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Peptide Synthesis Fully automated and manual methods Milligram to hundred gram range Solid or solution phase Peptide immunogens Peggylated Peptides Biotinylated Peptides Chromogens, Fluorogens Radiolabeled Peptides Incorporation of Stable Isotopes Non-natural amino acids


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Immunochemistry Immunogen / epitope preparation and characterization Monoclonal antibodies

Cell line characterization (cell biology, genome, proteome, adventitious agents) ELISA development for screening Immunization and screening Fusion and screening of hybridomas Cloning and ascites production

Polyclonal antibodies Monospecific polyclonal antibodies

Immobilization of antigen to matrix Purification antisera by affinity chromatography


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ELISA Development

Direct, indirect, and sandwich ELISAs Screening and characterization of biologics Biomarkers Assay Validation


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Nucleic Acid Chemistries Genomics

Detection of sequence variants using SNP analysis or DNA sequencing Pharmacogenomics Gene expression analysis with micro arrays RNAi knock out Bioinformatics: Sequence annotation and assembly, comparative genomics,

BLAST/FAST and Gene/ORF

Custom Molecular Assays PCR-Taqman Real-time PCR Protocols and assays from sequence data or RNA


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Nucleic Acid Chemistries

DNA Sequence Analysis Controlled DNA shearing Shotgun Gap filling BACs, PACs, YACs Normalized/subtracted cDNA libraries Next Gen Sequence (NGS) Analysis (Roche Flex and GS Junior)


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Molecular Biology Custom gene synthesis, primer and probe design Mutagenesis High through-put cloning Plasmid preparation Northern and Southern blots Bacterial and viral genomes Adventitious agent testing


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Recombinants and Over Expression

From Paper to Product Recombinants

Constructs can be developed from DNA or protein sequence data de novo gene synthesis or PCR amplification of encoding sequence from genomic or

plasmid DNA Proteins can be designed with any purification tag (His Tag, GST-Tag)

Expression systems Bacteria, Yeast, CHO, COS, Insect Cells

Small scale fermentation to assess expression levels and characterize protein• Bacteria and Yeast (100L), • Mammalian Cell Culture (50L) • Insect Cells (100L)

Strategic Industry Partners for large volume fermenations and cultures Purification and characterization


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Microbiology/Virology General microbiology Pathogen detection BSL-3 facilities Biosafety

Detection, identification, and quantitation of biopharmaceutical raw materials and process validation

In vitro assays Adventitious agents and Mycoplasma Toxins and endotoxins Residual DNA/protein PERT assay for retrovirus enzymes Sterility testing

Human virus detection in blood-derived products

HIV, HTLV, HBV, EBV, CMV, HCV, Adenovirus PCR-based detection, ELISA, PERT

Plaque Assays, Plaque Reduction Assays


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Clinical Trial Support Services

Safety, efficacy and potency of biologics

Primary endpoints Esoteric safety assays Biomarkers Immunogenic response Biologics characterization

Support Central Lab testing by Sponsors and 3rd party Central Labs

CLIA, CAP, cGCP Lab

Vaccines including BSL-3 Gene therapies Therapeutic antibodies and

peptides Recombinant proteins Real Time PCR Mutation Detection Clinical Genetics Clinical Immunochemistry,

Protein Chemistry, Bioanalytics


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Paternity Testing (Private, State, Immigration) CODIS Services Forensics Services Mitochondrial DNA (mtDNA) sequencing Y-chromosome STR Analysis Specimen Matching CID Personal DNA Profiling

DNA Reference Lab ActivitiesFairfax Identity Lab


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Pre-Clinical Services

GLP production and technology transfer to 3rd party GMP

Peptides Vaccines and challenge material (BSL-3) Recombinant proteins

Bio-Manufacturing support Cell bank characterization Protein characterization and stability Bio-pharmaceutical potency assay development Bio-safety testing Lot release for safety, purity, potency

Custom Bio-Analytics for preclinical studies (GLP)

Assay development for assessing biologics safety and efficacy in animal studies

Assay development for assessing immunogenicity and immune system function

Ligand binding studies for protein / peptide therapies and targets

Specialty molecular-biology assay development, GLP sequencing

Microbiology / Virology BSL-3 assay development

Assay of specimens requiring BSL-3


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Bio-ManufacturingSupport

Custom potency development and testing

Cell bank characterization Protein characterization and

stability Endotoxin analysis and

residual organics Genetic characterization,

molecular biology assays and residual DNA

Virology, detection of adventitious agents, retroviruses, viral clearance, PCR assays

Detection of replication competent viruses for vaccines and gene therapies

Mycoplasma Lot release for safety, purity,

and potency


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Validation Studies Done at AI BiotechMLVA analysis of anthracis strainsMass spec analysis of ricin/abrinVEE plaque and plaque reduction assays Butyrylcholinesterase as a scavenger for CW agentsEarly cancer antigen ELISAmtDNA analysisMicrosatellite assay for Bladder Cancer detectionRP HPLC, AAA, mass spec analysis of PM 102Botox Immunogenicity assayDS enzyme, immunogenicity, and neutralization assays Peptide Immunogenicity assays DS LC/MS, RP HPLC assays


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Bostwick Laboratories, Inc.Central Lab Capabilities

Central Laboratory Services for Phase I-IV Clinical Trials and Device StudiesCentral Laboratory Services for Phase I-IV Clinical Trials and Device Studies Anatomic PathologyAnatomic Pathology Digital PathologyDigital Pathology Clinical PathologyClinical Pathology Molecular PathologyMolecular Pathology

BiomarkersBiomarkers CytogeneticsCytogenetics Protein Expression AnalysisProtein Expression Analysis

Clinical TestingClinical Testing Testing of Blood & UrineTesting of Blood & Urine MicrobiologyMicrobiology CytologyCytology FISH (one of the largest in North America)FISH (one of the largest in North America)

Electron Microscopy Analysis Electron Microscopy Analysis


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AI Biotech Contacts Robert B. Harris, Ph.D., President/CSO

Phone 804 915 3840; email: [email protected] Thomas R. Reynolds, VP, Sci Technology

Phone 804 915 3830; email: [email protected] Russell L. Wolz, Ph.D., Director, Biological Chemistries

Phone 804 521 3848; email: [email protected] Karen Carter, Ph.D., Group Leader, Bioorganic Chemistries

Phone: 804 521 7369; email: [email protected] Daniel R Davis, Group Leader, Bioanalytics

Phone: 804 915 3824; email: [email protected] Sarah Helber, Ph.D., Director, Clinical Services

Phone: 804 915 3853; email: [email protected] Gregory A Meyers, Director, Molecular Biology

Phone: 804 915 3838; email: [email protected]