Biodextris Presentation - New client presentation

biode tris
Analytical 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
Analytical Development
Companies choose to work with us because we are experts in developing complete analytical
packages for novel and complex vaccine and biologic products.
Process Development
Companies 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 Testing
Companies rely on our Quality Control testing services for their clinical phase vaccines and
biologics. cGMP studies are conducted following FDA and EMA guidelines.
Biomanufacturing
Companies 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
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
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.

Legacy Track Record
2005 - 2015
5
Area Compound Disease Area Phase Deliverables Result Leadership
Vaccine
Protein 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
Influenza
HxNx 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 aggregates
P – 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
Products and applications
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

Biophysical Assays
• 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.

Physiochemical Assays
• 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

Immunological Assays
• Western Blot
→ Size separation and antigen specificity characterization
• ELISA: Enzyme-Linked Immunosorbent Assay
→ Antigenic activity and identification
• SRID: Single Radial Immunodiffusion
→ Hemagglutinin potency assay

Microbial Characterisation Assays
• 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.

Quality Management
Quality Control and Stability Testing
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.

bioprocess development
Products and applications
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

Upstream Fermentation
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

Downstream Purification
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

Formulation
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

bioproduction services
Non-cGMP Production
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.

biotransfer services
Technology Transfer to large-scale GMP
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.

CMC Consulting Services
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.

Project Management
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

How to find us
Greater Montreal Region, Canada
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
Joseph Zimmermann President and CEO
Ph.D. - Biochemical Engineering
Massachusetts 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) - Physics
University of Melbourne
16 years experience in vaccine and biopharmaceutical process development and
manufacturing.
Christine Jacques Analytical Services Director
M.Sc. - Applied Microbiology
INRS-Institut Armand-Frappier
16 years experience in analytical method development for vaccines and biologics.

bioprocess
biomolecular
bioproduction
biotransfer
biode tris
28

Biodextris Presentation - New client presentation

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