Biodextris Presentation - New client presentation

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    08-Feb-2017

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  • biode trisAnalytical and process development

    services for vaccines and biologics

  • Introduction

    What we do

    +1-450-965-8213 x100 info@biodextris.com 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 info@biodextris.com 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 info@biodextris.com 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 info@biodextris.com www.biodextris.com

  • biomolecular analytics

    6

  • biomolecular analytics

    Products and applications

    +1-450-965-8213 x100 info@biodextris.com 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 info@biodextris.com 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 info@biodextris.com 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 info@biodextris.com 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 info@biodextris.com 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 info@biodextris.com 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 info@biodextris.com www.biodextris.com 15

    Our team has comprehensive experience in process development of complex biological products such as:

    Recombinant purified proteins Cell membrane preparations Complex multi-component systems Whole cell based products

    We are differentiated through our experience in applying biotechnology techniques toward the clinical and commercial development of complex biologics in a regulated industry. This approach can be applied to the development of:

    Vaccines Biologics, Biopharmaceuticals Diagnostics, Biological reference standards Commercial enzymes

  • bioprocess development

    Upstream Fermentation

    +1-450-965-8213 x100 info@biodextris.com www.biodextris.com 16

    Services:

    Media and host evaluation in flask or bioreactors Scale-up from laboratory to pilot-scale. Batch or fed-batch protocols. Process screening and optimization by DoE (Design

    of Experiments)

    Capabilities:

    15 L bioreactors High pressure cell disruption Microbial viability, purity and identity tests Biomass, metabolite & nutrient analysis Product yield and quality analysis by electrophoresis

    and HPLC

  • bioprocess development

    Downstream Purification

    +1-450-965-8213 x100 info@biodextris.com www.biodextris.com 17

    Services:

    High-throughput resin screening Protein compatibility studies Product Process Robustness Short-term stability studies Thermodynamic assessment

    Capabilities:

    High pressure cell disruption AKTA Avant and Pilot systems IEX, HIC, RP, SEC Chromatography Tangential flow filtration Sterile filtration DSC, HPLC, MS and FFF analysis

  • bioprocess development

    Formulation

    +1-450-965-8213 x100 info@biodextris.com www.biodextris.com 18

    Services:

    Excipient screening Protein compatibility studies Stress testing Short-term stability studies

    Capabilities:

    Sterile Liquid formulations Multi-component presentations Colorimetry, Particle Size, Turbidometry Immunological characterization

  • 19

    bioproduction services

  • bioproduction services

    Non-cGMP Production

    +1-450-965-8213 x100 info@biodextris.com www.biodextris.com 20

    We offer small and medium-scale protein manufacturing capacity, ranging from milligrams to tens of grams per batch. A strong emphasis is placed on production of high quality products in which the process is well documented and the product well characterized.

    This capacity is an effective manufacturing platform for high quality proteins in numerous application fields: Diagnostic, Processing or Environmental enzymes Research reagents Target proteins for high-throughput screening activities Tagged proteins for discovery and pre-clinical Monoclonal antibodies Cytokines

    Our team possesses a strong integrated expertise in recombinant protein production, and collectively decades of experience in the manufacture of proteins for the healthcare and life-science industry in both research and production environments.

    Our management team has overseen the production of a variety of protein and cell-based products for use in preclinical, toxicology and clinical studies as well as several diagnostic products.

  • 21

    biotransfer services

  • biotransfer services

    Technology Transfer to large-scale GMP

    +1-450-965-8213 x100 info@biodextris.com www.biodextris.com 22

    Following process development or early clinical production, transfer and scale-up to large-scale clinical or commercial manufacturing can be managed in partnership with CMOs or directly with customer production sites.

    Our team has broad experience in technical transfer of upstream, downstream and secondary production processes to pilot and production scale partner GMP facilities. Receiving sites have included small and medium sized biotechnology companies, large pharmaceutical and large vaccine manufacturers, government organizations and CMOs, located in the US, Canada and Europe.

    Through this experience we have optimized a systematic approach to process and analytical transfer that includes key components: Control of scale-related process variations Control of equipment related variations Performance of transfer lots Management of the transfer process Operator Training Documentation and knowledge management

    Appropriate project management and implementation of individual technology transfer elements is important for streamlined time-lines, cost containment and risk minimization.

  • biotransfer services

    CMC Consulting Services

    +1-450-965-8213 x100 info@biodextris.com www.biodextris.com 23

    Our staff has decades of experience in developing and manufacturing products for the healthcare industry in both cGMP and non-cGMP environments, and are well positioned to offer the support needed to ensure your products meet all quality and regulatory requirements.

    We support our clients to ensure compliance with all applicable regulations. Our experts compile and review all data and documentation needed for regulatory CMC submissions to help our clients make their product a success on the market.

    Services include Guidance on quality standards for regulatory submissions. Creation of product monographs, analytical release specifications and stability study plans. Expert quality reviews of production protocols and analytical methods. Drafting and preparation of CMC (IND) documentation.

  • biotransfer services

    Project Management

    +1-450-965-8213 x100 info@biodextris.com www.biodextris.com 24

    Our experienced management team will work with you to develop an optimal project plan in accordance with project management best practices including: Timeline scheduling Work Breakdown Structure (WBS) Budget compilation Risk management

    Our flexible communication strategy includes: Periodic project review via teleconferences or face to face meetings Update/reports on deliverables, performance and budget adherence. Scientific development reports and summary presentations

  • 25

    company information

  • How to find us

    Greater Montreal Region, Canada

    +1-450-965-8213 x100 info@biodextris.com www.biodextris.com 26

    Biodextris: Head Office

    46 Rue de Saint-Tropez,

    Kirkland, QC, H9J 2R6, Canada

    +1-450-965-8213 x100

    info@biodextris.com

    www.biodextris.com

    Biodextris: Laboratory

    525 Boulevard Cartier Ouest,

    Laval, QC, H7V 3S8, Canada

  • Leadership Team

    Management and Founding Partners

    +1-450-965-8213 x100 info@biodextris.com www.biodextris.com 27

    Joseph Zimmermann President and CEOPh.D. - Biochemical EngineeringMassachusetts Institute of Technology (MIT)

    25 years in leadership roles at life-science companies focussed on vaccines, protein based drugs and diagnostics.

    Paul Rice Process Services Director B.Sc. (Hons) - PhysicsUniversity of Melbourne

    16 years experience in vaccine and biopharmaceutical process development and manufacturing.

    Christine Jacques Analytical Services DirectorM.Sc. - Applied MicrobiologyINRS-Institut Armand-Frappier

    16 years experience in analytical method development for vaccines and biologics.

  • bioprocess

    biomolecular

    bioproduction

    biotransfer

    biode tris28