Biodextris Presentation - New client presentation

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Transcript of Biodextris Presentation - New client presentation

  • biode trisAnalytical and process development

    services for vaccines and biologics

  • Introduction

    What we do

    +1-450-965-8213 x100 [email protected] www.biodextris.com 2

    Biodextris specializes in providing analytical method development, process development and quality control testing services to companies in the clinical phases of vaccines and biologics product development.

    Comprised of experienced product development scientist located in Laval (Montreal), Quebec, the group has worked together since 2002, as part of ID Biomedical and later GSK-Vaccines. We have developed numerous products for all phases of clinical development for programs conducted in the US, Canada and Europe.

    Our history leaves us with the know-how for high quality, robust, commercial product development combined with flexibility and the sense of urgency inherent in smaller organizations.

    We look forward to sharing this expertise with you.

  • Introduction

    Services at a Glance

    +1-450-965-8213 x100 [email protected] www.biodextris.com 3

    Analytical DevelopmentCompanies choose to work with us because we are experts in developing complete analytical packages for novel and complex vaccine and biologic products.

    Process DevelopmentCompanies trust us to accelerate their project from the bench to the clinic. We rapidly deliver robust and reliable production processes ready for manufacturing of your vaccine or biologic.

    QC and Stability TestingCompanies rely on our Quality Control testing services for their clinical phase vaccines and biologics. cGMP studies are conducted following FDA and EMA guidelines.

    BiomanufacturingCompanies depend on our all-inclusive biomanufacturing services to produce high quality non-GMP biologic material essential for their discovery, pre-clinical or diagnostic programs.

  • Organizational History

    1999 - 2015

    +1-450-965-8213 x100 [email protected] www.biodextris.com 4

    199920002001200220032004200520062007200820092010201120122013201420152016

    Start-up Biotechnology Company Proprietary Adjuvant Two clinical development programs 40 employees

    Mid-size Biotechnology Company Two clinical development programs 800 employees

    Vaccines Division of Big Pharma Three clinical programs One marketed vaccine

    Multinational Vaccine Big Pharma

    > 12,000 employees

    Majority of staff have been working together for more than 10 years

    Experienced from small Biotechnology to Big Pharma

    Our approach combines a small companys flexibility with experience in developing processes for manufacturing of complex biologics for a large multinational corporation.

    http://www.google.ca/url?url=http://gskmorethanmedicine.com/&rct=j&frm=1&q=&esrc=s&sa=U&ei=yoedVK7EJo2raev5gTg&ved=0CBUQ9QEwAA&sig2=2dpGeUfqCHO87l2rtFv1oA&usg=AFQjCNFy0KCqTAnqImUS6gRNG-TO7XzVSQhttp://www.shire.com/shireplc/

  • Legacy Track Record

    2005 - 2015

    5

    Area Compound Disease Area Phase Deliverables Result Leadership

    VaccineProtein Antigen Bacterial P1 Process Dev. Transfer GMP, Analytical Dev. QC On time T

    Protein Antigen Bacterial P1 Process Dev. Transfer GMP, Analytical Dev. QC On time T

    Membrane Protein Complex Bacterial PC Process Dev. and Analytical Dev. On time T

    Protein Antigen Bacterial PC Process Dev. and Analytical Dev. On time T

    Immunotherapy

    Conjugate Protein Addiction P3 Analytical Dev. On time

    Membrane Protein Complex Alzheimer P1 Process Dev. Transfer GMP, Analytical Dev. QC On time P/T

    Carrier Protein Addiction P3 Analytical Dev. On time

    Protein Antigen Cancer P1 Process Dev. Transfer GMP, Analytical Dev. QC Late 6 mo1 P/T

    Protein Antigen Cancer P1 Process Dev. Transfer GMP, Analytical Dev. QC Late 3 mo2 P/T

    Protein Antigen Cancer PC Process Dev. Transfer GMP, Analytical Dev. QC On time P/T

    Protein Antigen Cancer P3 Analytical Dev. and QC On time P/T

    Protein Antigen Cancer P1 Process Dev. Transfer GMP, Analytical Dev. QC On time P/T

    VLP Antigen Viral P1 Process Dev. Transfer GMP, Analytical Dev. QC On time

    InfluenzaHxNx Influenza/Pandemic P1 Analytical Dev. and QC On time

    HA Influenza/Seasonal P4 Analytical Dev. On time

    Strain ID Influenza/Seasonal P4 Analytical Dev. On time

    Flu IN Influenza/Seasonal P2 Process Dev. Transfer GMP, Analytical Dev. QC On time P/T

    Adjuvant Novel Adjuvant Novel Adjuvant P2 Process Dev. Transfer GMP, Analytical Dev. QC On time P/T

    Carrier Protein Carrier Protein P3 Analytical Dev On time

    Innate Inactivated whole-cell Immunobiotic Respiratory PC Process Dev. Transfer GMP, Analytical Dev. QC On time T

    1 GMP delayed 6 months to address issues associated with antigen-adjuvant compatibility.2 GMP delayed 3 months to address issues associated with retention of LPS in protein aggregatesP project leader, T technical leader, PC preclinical, P1 Phase 1, P2 Phase 2, P3- Phase 3, P4 Phase 4 (life cycle)

    Broad experience in early clinical stage product development with project leadership roles 90 % of major milestones delivered on-time, within 5% of yearly budget during this time frame Expertise in microbial-based recombinant proteins, whole-cell products or cell-extract formulations

    +1-450-965-8213 x100 [email protected] www.biodextris.com

  • biomolecular analytics

    6

  • biomolecular analytics

    Products and applications

    +1-450-965-8213 x100 [email protected] www.biodextris.com 7

    We offer a range of solutions for product characterization and development activities for variety of GLP and cGMP applications including:

    Biopharmaceuticals Vaccines Biologics Diagnostics Commercial enzymes Biological reference standards

    We apply a robust systematic Quality driven approach to method development and subsequent data acquisition activities that can be applied for multiple purposes:

    Assay development, qualification and validation Determination of product specifications Product characterization Quality control release testing under cGMP Stability studies under cGMP

  • biomolecular analytics

    Biophysical Assays

    +1-450-965-8213 x100 [email protected] www.biodextris.com 8

    SEC-MALS: Size-exclusion Chromatography with Multi-Angle Light Scattering Direct molar mass and size distribution

    SEC-FLUO: Fluorescence-detection Size-exclusion Chromatography Aggregation determination

    FFF-MALS: Field Flow Fractionation with Multi-Angle Light Scattering Molar Mass and size distribution determination

    DLS: Dynamic Light scattering Particle size and size distribution determination.

  • biomolecular analytics

    Physiochemical Assays

    +1-450-965-8213 x100 [email protected] www.biodextris.com 9

    HPLC/UPLC-RP/IEX/SEC: High/Ultra Performance Liquid Chromatography with Reverse Phase/Ion-Exchange/Size-Exclusion

    Content or purity determination

    SDS-PAGE: Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis Size separation and purity determination

    GC-MS: Gas-Chromatography Mass Spectrometry Separation, identification and quantification

    ICP: Inductively-Coupled Plasma Trace element identification

    LC-MS/MS: Liquid Chromatography - Tandem Mass Spectroscopy Multi-analyte determination

    Threshold DNA Quantification of target or residual DNA

    LAL Endotoxin: Limulus amebocyte lysate assay Quantification of residual LPS or endotoxin

    Colorimetry Color determination

  • biomolecular analytics

    Immunological Assays

    +1-450-965-8213 x100 [email protected] www.biodextris.com 10

    Western Blot Size separation and antigen specificity characterization

    ELISA: Enzyme-Linked Immunosorbent Assay Antigenic activity and identification

    SRID: Single Radial Immunodiffusion Hemagglutinin potency assay

  • biomolecular analytics

    Microbial Characterisation Assays

    +1-450-965-8213 x100 [email protected] www.biodextris.com 11

    Microscopic examination, e.g. Gram Stain, hemocytometry Strain identity, enumeration

    Phenotypic Identification - solid media Strain identity

    Antigen Identification e.g. ELISA, Western Blot Strain/Product identity

    Culture Purity - selective solid media Culture Purity

    Colony Forming Units solid media Enumeration and viability

    Plasmid Retention Determination of culture population retaining expression plasmid.

  • 12

    quality management

  • Quality Management

    Quality Control and Stability Testing

    +1-450-965-8213 x100 [email protected] www.biodextris.com 13

    Our transparent, audit-ready Quality Management System (QMS) ensures regulatory compliance and data integrity, enabling cGMP compliant analytical testing for Quality Control (QC) and Stability programs. Critical elements include:

    Quality policies and Quality Manual Standard Operating Procedures (SOPs) Validation Master Plan Sample management Deviation management Calibration and Preventative maintenance Change Control Document Control Incident management Risk management process Training management Organizational roles and responsibilities

    We manage process and product knowledge throughout your project, and implement clear and precise communication channels. Our information systems safely store your data and comply with requirements of regulatory and intellectual property agencies.

  • 14

    bioprocess development

  • bioprocess development

    Products and applications

    +1-450-965-8213 x100 [email protected] www.biodextris.com 15

    Our team has comprehen