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 comprehen