CAPABILITIES OVERVIEW Adam H. Libby, Ph.D. Business Development Manager 601 Biotech Dr Richmond, VA 23235 Phone: 804 385 3...
Contract Research Laboratory <ul><li>Integrated Project Support for   </li></ul><ul><li>Development and Manufacturing of  ...
A Focus on Early Stage Discovery and Development Target Identification pre-clinical testing clinical testing client CROs D...
AI BioTech is a Division of Bostwick Laboratories, Inc. Virginia Florida New York  United Kingdom (London) AIBioTech,  Vir...
AI BioTech, Richmond, VA <ul><li>Staff </li></ul><ul><li>70 employees  </li></ul><ul><ul><li>70% scientists, Ph.Ds, M.S., ...
Facilities and Quality <ul><li>Facility Operations </li></ul><ul><li>32,000 sq ft and GLP Compliant </li></ul><ul><li>BSL-...
Strengths <ul><li>Broad Ranging Expertise </li></ul><ul><ul><li>scientists with a broad range of expertise and practical e...
Key Differentiators <ul><li>Focus exclusively on laboratory services </li></ul><ul><li>Customized assays along the drug de...
AI BioTech is a GLP Facility <ul><li>Operates under Good Laboratory Practices (GLP) Guidelines (21 CFR 58). </li></ul><ul>...
Core Enabling Technologies
Core Laboratory Functions <ul><li>Protein Chemistry </li></ul><ul><li>Bioanalytics </li></ul><ul><li>Bioorganic Chemistry ...
Protein Chemistry <ul><li>Proteomics </li></ul><ul><ul><li>Proteome maps from 2-D gels and other systems </li></ul></ul><u...
Bioanalytics <ul><li>Calorimetry (ITC, DSC)  </li></ul><ul><li>Spectroscopies (CD, Fluorescence, UV/Vis, Light Scattering)...
Bioorganic Chemistry <ul><li>Design and Optimization of Synthesis routes </li></ul><ul><li>Milligram to hundred gram scale...
Peptide Synthesis <ul><li>Fully automated and manual methods </li></ul><ul><li>Milligram to hundred gram range </li></ul><...
Immunochemistry <ul><li>Immunogen / epitope preparation and characterization </li></ul><ul><li>Monoclonal antibodies </li>...
ELISA Development <ul><li>Direct, indirect, and sandwich ELISAs </li></ul><ul><li>Screening and characterization of biolog...
Nucleic Acid Chemistries <ul><li>Genomics  </li></ul><ul><ul><li>Detection of sequence variants using SNP analysis or DNA ...
Nucleic Acid Chemistries <ul><li>DNA Sequence Analysis </li></ul><ul><ul><li>Controlled DNA shearing </li></ul></ul><ul><u...
Molecular Biology <ul><li>Custom gene synthesis, primer and probe design </li></ul><ul><li>Mutagenesis </li></ul><ul><li>H...
Recombinants and  Over Expression From Paper to Product <ul><li>Recombinants </li></ul><ul><ul><li>Constructs can be devel...
Microbiology/Virology <ul><li>General microbiology </li></ul><ul><li>Pathogen detection </li></ul><ul><li>BSL-3 facilities...
Clinical Trial Support Services <ul><li>Safety, efficacy and potency of biologics </li></ul><ul><ul><li>Primary endpoints ...
<ul><li>Paternity Testing (Private, State, Immigration) </li></ul><ul><li>CODIS Services </li></ul><ul><li>Forensics Servi...
Pre-Clinical Services <ul><li>GLP production and technology transfer to 3 rd  party GMP </li></ul><ul><ul><li>Peptides </l...
Bio-Manufacturing Support <ul><li>Custom potency development and testing </li></ul><ul><li>Cell bank characterization </li...
Validation Studies Done at AI Biotech <ul><li>MLVA analysis of anthracis strains </li></ul><ul><li>Mass spec analysis of r...
Bostwick Laboratories, Inc. Central Lab Capabilities <ul><li>Central Laboratory Services for Phase I-IV Clinical Trials an...
AI Biotech Contacts <ul><li>Robert B. Harris, Ph.D., President/CSO   </li></ul><ul><ul><li>Phone 804 915 3840; email:  [em...
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Ai Biotech Mktg Overview 0411

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Ai Biotech Mktg Overview 0411

  1. 1. CAPABILITIES OVERVIEW Adam H. Libby, Ph.D. Business Development Manager 601 Biotech Dr Richmond, VA 23235 Phone: 804 385 3294 Phone: 800 269 4822 Email: [email_address]
  2. 2. Contract Research Laboratory <ul><li>Integrated Project Support for </li></ul><ul><li>Development and Manufacturing of </li></ul><ul><li>Biologics and Specialty Diagnostics </li></ul>Biologics Specialty Diagnostics AI Biotech Bio Molecular Technologies
  3. 3. A Focus on Early Stage Discovery and Development Target Identification pre-clinical testing clinical testing client CROs Drug Candidates AI Biotechnology Services
  4. 4. AI BioTech is a Division of Bostwick Laboratories, Inc. Virginia Florida New York United Kingdom (London) AIBioTech, Virginia
  5. 5. AI BioTech, Richmond, VA <ul><li>Staff </li></ul><ul><li>70 employees </li></ul><ul><ul><li>70% scientists, Ph.Ds, M.S., B.S. </li></ul></ul><ul><ul><li>20 % Administration, IT, Sales and Marketing </li></ul></ul><ul><ul><li>10% Quality assurance and Regulatory Compliance </li></ul></ul><ul><li>Clients </li></ul><ul><li>Serviced over 5,500 clients in more than 2,500 institutions world-wide. >30% repeat clients </li></ul><ul><ul><li>80% Commercial Organizations </li></ul></ul><ul><ul><li>5% Academic Centers </li></ul></ul><ul><ul><li>15% Government Institutions </li></ul></ul>
  6. 6. Facilities and Quality <ul><li>Facility Operations </li></ul><ul><li>32,000 sq ft and GLP Compliant </li></ul><ul><li>BSL-3 laboratories for bacterial and viral agents </li></ul><ul><li>LICENSES, REGISTRATIONS, CERTIFICATIONS </li></ul><ul><li>CLIA – Clinical Laboratory Improvement Act </li></ul><ul><ul><li>Allows for testing of human samples </li></ul></ul><ul><li>CAP – College of American Pathologists </li></ul><ul><ul><li>Certified clinical testing lab, licensed in all States (New York Pending) </li></ul></ul><ul><li>AABB – American Association of Blood Banks </li></ul><ul><ul><li>Human genetics & genotyping </li></ul></ul><ul><li>ISO/IEC 17025:2205 FRA1 and FRA 2 </li></ul><ul><ul><li>Forensic DNA analysis </li></ul></ul><ul><li>NFSTC – National Forensic Science Technology Council </li></ul><ul><ul><li>Forensic DNA analysis </li></ul></ul><ul><li>USDA – United States Department of Agriculture </li></ul><ul><ul><li>Allows for testing of animal samples and handling plant & animal pathogens </li></ul></ul><ul><li>NRC – Nuclear Regulatory Commission </li></ul><ul><ul><li>Radioisotope use </li></ul></ul><ul><li>DEA – Drug Enforcement Agency </li></ul><ul><ul><li>Class 1 – 6 controlled substances </li></ul></ul><ul><li>CDC Select Agent Registration </li></ul><ul><ul><li>Allows for handling of bio-threat organisms & toxins </li></ul></ul>
  7. 7. Strengths <ul><li>Broad Ranging Expertise </li></ul><ul><ul><li>scientists with a broad range of expertise and practical experience in an array of disciplines. </li></ul></ul><ul><li>Breadth of Technologies </li></ul><ul><ul><li>state-of-the-art technologies, providing a range of options to solve almost any problem. </li></ul></ul><ul><li>A Collaborative Culture </li></ul><ul><ul><li>a stimulating, open environment where scientists collaborate among themselves and with our clients, taking on interesting challenges and developing creative solutions </li></ul></ul>
  8. 8. Key Differentiators <ul><li>Focus exclusively on laboratory services </li></ul><ul><li>Customized assays along the drug development continuum </li></ul><ul><li>Specialize in Biologics / Bio-Pharmaceuticals </li></ul><ul><li>Flexible Outsourcing Model </li></ul><ul><ul><li>Extension of Your Lab to fill in capacity </li></ul></ul><ul><ul><li>Consultative and collaborative for special expertise </li></ul></ul><ul><li>Direct access to scientists </li></ul><ul><ul><li>Senior scientists develop SOW and project fulfillment </li></ul></ul>
  9. 9. AI BioTech is a GLP Facility <ul><li>Operates under Good Laboratory Practices (GLP) Guidelines (21 CFR 58). </li></ul><ul><li>Approved Laboratory Quality Assurance Plan </li></ul><ul><li>Approximately 500 SOPs in Support of Our Broad Technology Base </li></ul>
  10. 10. Core Enabling Technologies
  11. 11. Core Laboratory Functions <ul><li>Protein Chemistry </li></ul><ul><li>Bioanalytics </li></ul><ul><li>Bioorganic Chemistry </li></ul><ul><li>Nucleic Acid Chemistry </li></ul><ul><li>Immunochemistry </li></ul><ul><li>Microbiology </li></ul><ul><li>Recombinants and Over Expression </li></ul><ul><li>DNA Reference Lab </li></ul><ul><li>Clinical Trial Support Services </li></ul><ul><li>Clinical Testing Services </li></ul>
  12. 12. Protein Chemistry <ul><li>Proteomics </li></ul><ul><ul><li>Proteome maps from 2-D gels and other systems </li></ul></ul><ul><ul><li>Isolate and characterize protein </li></ul></ul><ul><ul><li>Bioinformatics </li></ul></ul><ul><li>Protein analysis, mapping, and sequencing </li></ul><ul><ul><li>Chromatographic mappping </li></ul></ul><ul><ul><li>Mass spectral analysis and mapping by MALDI-TOF/MS, LC/MS, </li></ul></ul><ul><ul><li>Mass spec sequence analysis by MSMS, automated Edman degradation. </li></ul></ul><ul><ul><li>C terminal sequence analysis </li></ul></ul><ul><ul><li>Amino acid analysis </li></ul></ul><ul><ul><li>Chromatographies </li></ul></ul><ul><ul><li>Electrophoresis </li></ul></ul>
  13. 13. Bioanalytics <ul><li>Calorimetry (ITC, DSC) </li></ul><ul><li>Spectroscopies (CD, Fluorescence, UV/Vis, Light Scattering) </li></ul><ul><li>Mass spectrometries (MALDI-TOF/MS, Q Tof LC/MS, Q Trap Triple Quad LC/MS) </li></ul><ul><li>GC/MS </li></ul><ul><li>HPLC </li></ul>
  14. 14. Bioorganic Chemistry <ul><li>Design and Optimization of Synthesis routes </li></ul><ul><li>Milligram to hundred gram scale </li></ul><ul><li>Pharmacophores, Inhibitors, Substrates, Carrier molecules </li></ul>
  15. 15. Peptide Synthesis <ul><li>Fully automated and manual methods </li></ul><ul><li>Milligram to hundred gram range </li></ul><ul><li>Solid or solution phase </li></ul><ul><li>Peptide immunogens </li></ul><ul><li>Peggylated Peptides </li></ul><ul><li>Biotinylated Peptides </li></ul><ul><li>Chromogens, Fluorogens </li></ul><ul><li>Radiolabeled Peptides </li></ul><ul><li>Incorporation of Stable Isotopes </li></ul><ul><li>Non-natural amino acids </li></ul>
  16. 16. Immunochemistry <ul><li>Immunogen / epitope preparation and characterization </li></ul><ul><li>Monoclonal antibodies </li></ul><ul><ul><li>Cell line characterization (cell biology, genome, proteome, adventitious agents) </li></ul></ul><ul><ul><li>ELISA development for screening </li></ul></ul><ul><ul><li>Immunization and screening </li></ul></ul><ul><ul><li>Fusion and screening of hybridomas </li></ul></ul><ul><ul><li>Cloning and ascites production </li></ul></ul><ul><li>Polyclonal antibodies </li></ul><ul><li>Monospecific polyclonal antibodies </li></ul><ul><ul><li>Immobilization of antigen to matrix </li></ul></ul><ul><ul><li>Purification antisera by affinity chromatography </li></ul></ul>
  17. 17. ELISA Development <ul><li>Direct, indirect, and sandwich ELISAs </li></ul><ul><li>Screening and characterization of biologics </li></ul><ul><li>Biomarkers </li></ul><ul><li>Assay Validation </li></ul>
  18. 18. Nucleic Acid Chemistries <ul><li>Genomics </li></ul><ul><ul><li>Detection of sequence variants using SNP analysis or DNA sequencing </li></ul></ul><ul><ul><li>Pharmacogenomics </li></ul></ul><ul><ul><li>Gene expression analysis with micro arrays </li></ul></ul><ul><ul><li>RNAi knock out </li></ul></ul><ul><ul><li>Bioinformatics: Sequence annotation and assembly, comparative genomics, BLAST/FAST and Gene/ORF </li></ul></ul><ul><li>Custom Molecular Assays </li></ul><ul><ul><li>PCR-Taqman </li></ul></ul><ul><ul><li>Real-time PCR </li></ul></ul><ul><ul><li>Protocols and assays from sequence data or RNA </li></ul></ul>
  19. 19. Nucleic Acid Chemistries <ul><li>DNA Sequence Analysis </li></ul><ul><ul><li>Controlled DNA shearing </li></ul></ul><ul><ul><li>Shotgun </li></ul></ul><ul><ul><li>Gap filling </li></ul></ul><ul><ul><li>BACs, PACs, YACs </li></ul></ul><ul><ul><li>Normalized/subtracted cDNA libraries </li></ul></ul><ul><ul><li>Next Gen Sequence (NGS) Analysis (Roche Flex and GS Junior) </li></ul></ul>
  20. 20. Molecular Biology <ul><li>Custom gene synthesis, primer and probe design </li></ul><ul><li>Mutagenesis </li></ul><ul><li>High through-put cloning </li></ul><ul><li>Plasmid preparation </li></ul><ul><li>Northern and Southern blots </li></ul><ul><li>Bacterial and viral genomes </li></ul><ul><li>Adventitious agent testing </li></ul>
  21. 21. Recombinants and Over Expression From Paper to Product <ul><li>Recombinants </li></ul><ul><ul><li>Constructs can be developed from DNA or protein sequence data </li></ul></ul><ul><ul><li>de novo gene synthesis or PCR amplification of encoding sequence from genomic or plasmid DNA </li></ul></ul><ul><ul><li>Proteins can be designed with any purification tag (His Tag, GST-Tag) </li></ul></ul><ul><li>Expression systems </li></ul><ul><ul><li>Bacteria, Yeast, CHO, COS, Insect Cells </li></ul></ul><ul><ul><ul><li>Small scale fermentation to assess expression levels and characterize protein </li></ul></ul></ul><ul><ul><ul><ul><li>Bacteria and Yeast (100L), </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Mammalian Cell Culture (50L) </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Insect Cells (100L) </li></ul></ul></ul></ul><ul><ul><ul><li>Strategic Industry Partners for large volume fermenations and cultures </li></ul></ul></ul><ul><li>Purification and characterization </li></ul>
  22. 22. Microbiology/Virology <ul><li>General microbiology </li></ul><ul><li>Pathogen detection </li></ul><ul><li>BSL-3 facilities </li></ul><ul><li>Biosafety </li></ul><ul><ul><li>Detection, identification, and quantitation of biopharmaceutical raw materials and process validation </li></ul></ul><ul><ul><li>In vitro assays </li></ul></ul><ul><ul><ul><li>Adventitious agents and Mycoplasma </li></ul></ul></ul><ul><ul><ul><li>Toxins and endotoxins </li></ul></ul></ul><ul><ul><ul><li>Residual DNA/protein </li></ul></ul></ul><ul><ul><ul><li>PERT assay for retrovirus enzymes </li></ul></ul></ul><ul><ul><ul><li>Sterility testing </li></ul></ul></ul><ul><ul><li>Human virus detection in blood-derived products </li></ul></ul><ul><ul><ul><li>HIV, HTLV, HBV, EBV, CMV, HCV, Adenovirus </li></ul></ul></ul><ul><ul><ul><li>PCR-based detection, ELISA, </li></ul></ul></ul><ul><ul><ul><li>PERT </li></ul></ul></ul><ul><ul><li>Plaque Assays, Plaque Reduction Assays </li></ul></ul>
  23. 23. Clinical Trial Support Services <ul><li>Safety, efficacy and potency of biologics </li></ul><ul><ul><li>Primary endpoints </li></ul></ul><ul><ul><li>Esoteric safety assays </li></ul></ul><ul><ul><li>Biomarkers </li></ul></ul><ul><ul><li>Immunogenic response </li></ul></ul><ul><ul><li>Biologics characterization </li></ul></ul><ul><li>Support Central Lab testing by Sponsors and 3 rd party Central Labs </li></ul><ul><li>CLIA, CAP, cGCP Lab </li></ul><ul><li>Vaccines including BSL-3 </li></ul><ul><li>Gene therapies </li></ul><ul><li>Therapeutic antibodies and peptides </li></ul><ul><li>Recombinant proteins </li></ul><ul><li>Real Time PCR </li></ul><ul><li>Mutation Detection </li></ul><ul><li>Clinical Genetics </li></ul><ul><li>Clinical Immunochemistry, Protein Chemistry, Bioanalytics </li></ul>
  24. 24. <ul><li>Paternity Testing (Private, State, Immigration) </li></ul><ul><li>CODIS Services </li></ul><ul><li>Forensics Services </li></ul><ul><li>Mitochondrial DNA (mtDNA) sequencing </li></ul><ul><li>Y-chromosome STR Analysis </li></ul><ul><li>Specimen Matching </li></ul><ul><li>CID Personal DNA Profiling </li></ul>DNA Reference Lab Activities Fairfax Identity Lab
  25. 25. Pre-Clinical Services <ul><li>GLP production and technology transfer to 3 rd party GMP </li></ul><ul><ul><li>Peptides </li></ul></ul><ul><ul><li>Vaccines and challenge material (BSL-3) </li></ul></ul><ul><ul><li>Recombinant proteins </li></ul></ul><ul><li>Bio-Manufacturing support </li></ul><ul><ul><li>Cell bank characterization </li></ul></ul><ul><ul><li>Protein characterization and stability </li></ul></ul><ul><ul><li>Bio-pharmaceutical potency assay development </li></ul></ul><ul><ul><li>Bio-safety testing </li></ul></ul><ul><ul><li>Lot release for safety, purity, potency </li></ul></ul><ul><li>Custom Bio-Analytics for preclinical studies (GLP) </li></ul><ul><ul><li>Assay development for assessing biologics safety and efficacy in animal studies </li></ul></ul><ul><ul><li>Assay development for assessing immunogenicity and immune system function </li></ul></ul><ul><ul><li>Ligand binding studies for protein / peptide therapies and targets </li></ul></ul><ul><ul><li>Specialty molecular-biology assay development, GLP sequencing </li></ul></ul><ul><ul><li>Microbiology / Virology BSL-3 assay development </li></ul></ul><ul><ul><li>Assay of specimens requiring BSL-3 </li></ul></ul>
  26. 26. Bio-Manufacturing Support <ul><li>Custom potency development and testing </li></ul><ul><li>Cell bank characterization </li></ul><ul><li>Protein characterization and stability </li></ul><ul><li>Endotoxin analysis and residual organics </li></ul><ul><li>Genetic characterization, molecular biology assays and residual DNA </li></ul><ul><li>Virology, detection of adventitious agents, retroviruses, viral clearance, PCR assays </li></ul><ul><li>Detection of replication competent viruses for vaccines and gene therapies </li></ul><ul><li>Mycoplasma </li></ul><ul><li>Lot release for safety, purity, and potency </li></ul>
  27. 27. Validation Studies Done at AI Biotech <ul><li>MLVA analysis of anthracis strains </li></ul><ul><li>Mass spec analysis of ricin/abrin </li></ul><ul><li>VEE plaque and plaque reduction assays </li></ul><ul><li>Butyrylcholinesterase as a scavenger for CW agents </li></ul><ul><li>Early cancer antigen ELISA </li></ul><ul><li>mtDNA analysis </li></ul><ul><li>Microsatellite assay for Bladder Cancer detection </li></ul><ul><li>RP HPLC, AAA, mass spec analysis of PM 102 </li></ul><ul><li>Botox Immunogenicity assay </li></ul><ul><li>DS enzyme, immunogenicity, and neutralization assays </li></ul><ul><li>Peptide Immunogenicity assays </li></ul><ul><li>DS LC/MS, RP HPLC assays </li></ul>
  28. 28. Bostwick Laboratories, Inc. Central Lab Capabilities <ul><li>Central Laboratory Services for Phase I-IV Clinical Trials and Device Studies </li></ul><ul><li>Anatomic Pathology </li></ul><ul><li>Digital Pathology </li></ul><ul><li>Clinical Pathology </li></ul><ul><li>Molecular Pathology </li></ul><ul><ul><li>Biomarkers </li></ul></ul><ul><ul><li>Cytogenetics </li></ul></ul><ul><ul><li>Protein Expression Analysis </li></ul></ul><ul><li>Clinical Testing </li></ul><ul><ul><li>Testing of Blood & Urine </li></ul></ul><ul><ul><li>Microbiology </li></ul></ul><ul><ul><li>Cytology </li></ul></ul><ul><ul><li>FISH (one of the largest in North America) </li></ul></ul><ul><li>Electron Microscopy Analysis </li></ul>
  29. 29. AI Biotech Contacts <ul><li>Robert B. Harris, Ph.D., President/CSO </li></ul><ul><ul><li>Phone 804 915 3840; email: [email_address] </li></ul></ul><ul><li>Thomas R. Reynolds, VP, Sci Technology </li></ul><ul><ul><li>Phone 804 915 3830; email: [email_address] </li></ul></ul><ul><li>Russell L. Wolz, Ph.D., Director, Biological Chemistries </li></ul><ul><ul><li>Phone 804 521 3848; email: [email_address] </li></ul></ul><ul><li>Karen Carter, Ph.D., Group Leader, Bioorganic Chemistries </li></ul><ul><ul><li>Phone: 804 521 7369; email: [email_address] </li></ul></ul><ul><li>Daniel R Davis, Group Leader, Bioanalytics </li></ul><ul><ul><li>Phone: 804 915 3824; email: [email_address] </li></ul></ul><ul><li>Sarah Helber, Ph.D., Director, Clinical Services </li></ul><ul><ul><li>Phone: 804 915 3853; email: [email_address] </li></ul></ul><ul><li>Gregory A Meyers, Director, Molecular Biology </li></ul><ul><ul><li>Phone: 804 915 3838; email: [email_address] </li></ul></ul>

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