biode trisAnalytical and process development
services for vaccines and biologics
What we do
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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.
Services at a Glance
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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.
1999 - 2015
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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.
Legacy Track Record
2005 - 2015
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
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
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Products and applications
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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
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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.
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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
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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
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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 Control and Stability Testing
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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.
Products and applications
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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
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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
15 L bioreactors High pressure cell disruption Microbial viability, purity and identity tests Biomass, metabolite & nutrient analysis Product yield and quality analysis by electrophoresis
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High-throughput resin screening Protein compatibility studies Product Process Robustness Short-term stability studies Thermodynamic assessment
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
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Excipient screening Protein compatibility studies Stress testing Short-term stability studies
Sterile Liquid formulations Multi-component presentations Colorimetry, Particle Size, Turbidometry Immunological characterization
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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.
Technology Transfer to large-scale GMP
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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.
CMC Consulting Services
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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.
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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
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Biodextris: Head Office
46 Rue de Saint-Tropez,
Kirkland, QC, H9J 2R6, Canada
525 Boulevard Cartier Ouest,
Laval, QC, H7V 3S8, Canada
Management and Founding Partners
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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.