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biode tris Analytical and process development services for vaccines and biologics

Biodextris Presentation - New client presentation

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Page 1: Biodextris Presentation - New client presentation

biode trisAnalytical and process development

services for vaccines and biologics

Page 2: Biodextris Presentation - New client presentation

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.

Page 3: Biodextris Presentation - New client presentation

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.

Page 4: Biodextris Presentation - New client presentation

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 company’s flexibility with experience in developing processes for manufacturing of complex biologics for a large multinational corporation.

Page 5: Biodextris Presentation - New client presentation

Legacy Track Record

2005 - 2015

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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

Page 6: Biodextris Presentation - New client presentation

biomolecular analytics

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Page 7: Biodextris Presentation - New client presentation

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

Page 8: Biodextris Presentation - New client presentation

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.

Page 9: Biodextris Presentation - New client presentation

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

Page 10: Biodextris Presentation - New client presentation

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

Page 11: Biodextris Presentation - New client presentation

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.

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quality management

Page 13: Biodextris Presentation - New client presentation

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 (SOP’s)

• 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.

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bioprocess development

Page 15: Biodextris Presentation - New client presentation

bioprocess development

Products and applications

+1-450-965-8213 x100 [email protected] 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

Page 16: Biodextris Presentation - New client presentation

bioprocess development

Upstream Fermentation

+1-450-965-8213 x100 [email protected] 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

Page 17: Biodextris Presentation - New client presentation

bioprocess development

Downstream Purification

+1-450-965-8213 x100 [email protected] 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

Page 18: Biodextris Presentation - New client presentation

bioprocess development

Formulation

+1-450-965-8213 x100 [email protected] 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

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bioproduction services

Page 20: Biodextris Presentation - New client presentation

bioproduction services

Non-cGMP Production

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

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biotransfer services

Page 22: Biodextris Presentation - New client presentation

biotransfer services

Technology Transfer to large-scale GMP

+1-450-965-8213 x100 [email protected] 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 CMO’s 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 CMO’s, 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.

Page 23: Biodextris Presentation - New client presentation

biotransfer services

CMC Consulting Services

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

Page 24: Biodextris Presentation - New client presentation

biotransfer services

Project Management

+1-450-965-8213 x100 [email protected] 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

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company information

Page 26: Biodextris Presentation - New client presentation

How to find us

Greater Montreal Region, Canada

+1-450-965-8213 x100 [email protected] www.biodextris.com 26

Biodextris: Head Office

46 Rue de Saint-Tropez,

Kirkland, QC, H9J 2R6, Canada

+1-450-965-8213 x100

[email protected]

www.biodextris.com

Biodextris: Laboratory

525 Boulevard Cartier Ouest,

Laval, QC, H7V 3S8, Canada

Page 27: Biodextris Presentation - New client presentation

Leadership Team

Management and Founding Partners

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

Page 28: Biodextris Presentation - New client presentation

bioprocess

biomolecular

bioproduction

biotransfer

biode tris28