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Biodextris

Laval, Quebec, CA

Biodextris is a contract research and development organisation, offering clients a reliable pathway to advance their biologic products from the research bench to clinical manufacturing.

We aim to provide clients with value-added process and analytical development services, employing technical expertise, commercial acumen and an emphasis on quality to efficiently bring your product to readiness for clinical phase production, which can be performed in collaboration with our regional GMP partners or your preferred manufacturing organisation.

Established in 2015 by scientists from the former GSK Vaccines R&D center in Laval (Montreal) Quebec, we offer upstream, downstream and formulation process development, analytical development and GMP QC release/stability testing, along with lab-scale manufacturing of research of protein-based biologics suitable for pre-clinical or diagnostic applications.

Combining the... Show more »

Biodextris is a contract research and development organisation, offering clients a reliable pathway to advance their biologic products from the research bench to clinical manufacturing.

We aim to provide clients with value-added process and analytical development services, employing technical expertise, commercial acumen and an emphasis on quality to efficiently bring your product to readiness for clinical phase production, which can be performed in collaboration with our regional GMP partners or your preferred manufacturing organisation.

Established in 2015 by scientists from the former GSK Vaccines R&D center in Laval (Montreal) Quebec, we offer upstream, downstream and formulation process development, analytical development and GMP QC release/stability testing, along with lab-scale manufacturing of research of protein-based biologics suitable for pre-clinical or diagnostic applications.

Combining the agility of a customer-focused biotech partner with years of foundational experience in mid-sized and multinational corporations, our team supports all technical and regulatory aspects of developing robust processes and analytical tools for complex biologic drug substance and drug products. Consulting and project management services are also offered in parallel.

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Biodextris has not listed any services.

ELISA
Enzyme-linked immunosorbent assay
Starting at $800.00 per sample

Method: Enzyme-Linked Immunosorbent Assay
Application: Antigenic activity and identification
Services: Immunological assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a... Show more »

Method: Enzyme-Linked Immunosorbent Assay
Application: Antigenic activity and identification
Services: Immunological assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Method proof-of-concept: starting from $16,800 CAD
  • Method development: starting from $16,800 CAD
  • Method qualification: starting from $16,800 CAD
  • QC assay initialization cost: starting from $1,000 CAD
  • QC assay cost per sample: starting from $800 CAD
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Spectramax
Molecular Devices Spectramax
Softmax Pro
Molecular Devices Softmax Pro
UPLC
Ultra performance liquid chromatography
Starting at $500.00 per sample

Method: High/Ultra Performance Liquid Chromatography with Reverse Phase/Ion-Exchange/Size-Exclusion
Application: Content or purity determination
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note:... Show more »

Method: High/Ultra Performance Liquid Chromatography with Reverse Phase/Ion-Exchange/Size-Exclusion
Application: Content or purity determination
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Method proof-of-concept: starting from $11,200 CAD
  • Method development: starting from $11,300 CAD
  • Method qualification: starting from $16,800 CAD
  • Assay initialization cost: starting from $1000 CAD
  • Cost per sample: starting from $500 CAD
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Waters Synapt G1
Synapt G1
Masslynx
Biopharmalynx
Western Blot
Starting at $1,000.00 per sample

Method: Western Blot
Application: Size separation and antigen specificity characterization
Services: Immunological assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a... Show more »

Method: Western Blot
Application: Size separation and antigen specificity characterization
Services: Immunological assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Method proof-of-concept: starting from $11,200 CAD
  • Method development: starting from $11,200 CAD
  • Method qualification: starting from $5,600 CAD
  • QC assay initialization cost: starting from $2000 CAD
  • QC assay cost per sample: starting from $1000 CAD
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DNA Quantification
Starting at $1,000.00 per sample

Method: DNA quantification by Threshold Immunoassay
Application: Quantification of target or residual DNA
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact... Show more »

Method: DNA quantification by Threshold Immunoassay
Application: Quantification of target or residual DNA
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Method proof-of-concept: starting from $5,600 CAD
  • Method development: starting from $5,600 CAD
  • Method qualification: starting from $11,200 CAD
  • Assay initialization cost: starting from $2000 CAD
  • Cost per sample: starting from $1000 CAD
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Molecular Devices Threshold
Threshold
Molecular Devices Threshold
Threshold
LC-MS/MS
Liquid chromatography tandem mass spectrometry
Starting at $1,000.00 per sample

Method: Liquid Chromatography - Tandem Mass Spectroscopy
Application: Multi-analyte determination
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a... Show more »

Method: Liquid Chromatography - Tandem Mass Spectroscopy
Application: Multi-analyte determination
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Method proof-of-concept: starting from $11,000 CAD
  • Method development: starting from $11,000 CAD
  • Method qualification: starting from $16,800 CAD
  • Assay initialization cost: starting from $1000 CAD
  • Cost per sample: starting from $1000 CAD
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GC-MS
Gas Chromatography Coupled Mass Spectrometry
Starting at $1,000.00 per sample

Method: Gas-Chromatography Mass Spectrometry.
Application: Separation, identification and quantification
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us... Show more »

Method: Gas-Chromatography Mass Spectrometry.
Application: Separation, identification and quantification
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Method proof-of-concept: starting from $11,200 CAD
  • Method development: starting from $11,200 CAD
  • Method qualification: starting from $16,800 CAD
  • Assay initialization cost: starting from $1000 CAD
  • Cost per sample: starting from $1000 CAD
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Agilent
Agilent GC
PAGE
Polyacrylamide Gel Electrophoresis
Starting at $500.00 per sample

Method: Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis with Coomassie or Silver stain.
Application: Size separation and purity determination
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability... Show more »

Method: Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis with Coomassie or Silver stain.
Application: Size separation and purity determination
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Method proof-of-concept: starting from $11,200 CAD
  • Method development: starting from $16,800 CAD
  • Method qualification: starting from $16,800 CAD
  • Assay initialization cost: starting from $1000 CAD
  • Cost per sample: starting from $500 CAD
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HPLC
High Performance Liquid Chromatography
Starting at $500.00 per sample

Method: High/Ultra Performance Liquid Chromatography with Reverse Phase/Ion-Exchange/Size-Exclusion
Application: Content or purity determination
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note:... Show more »

Method: High/Ultra Performance Liquid Chromatography with Reverse Phase/Ion-Exchange/Size-Exclusion
Application: Content or purity determination
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Method proof-of-concept: starting from $11,200 CAD
  • Method development: starting from $11,200 CAD
  • Method qualification: starting from $16,800 CAD
  • Assay initialization cost: starting from $1000 CAD
  • Cost per sample: starting from $500 CAD
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Waters
Empower
Differential Scanning Calorimetry (DSC)
Starting at $500.00 per sample

Method: Differential Scanning Colorimetry
Application: Phase (e.g. Glass) transition determination
Services: Biophysical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a... Show more »

Method: Differential Scanning Colorimetry
Application: Phase (e.g. Glass) transition determination
Services: Biophysical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Method proof-of-concept: starting from $5,600 CAD
  • Method development: NA
  • Method qualification: starting from $11,200 CAD
  • Assay initialization cost: starting from $1000 CAD
  • Cost per sample: starting from $500 CAD
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Malvern VP-DSC
VP-DSC
Origin
Micro-cal
Product Stability Testing
Price on request

We manage long-term and accelerated stability studies under GMP compliance to ensure the safety and efficacy of your candidate products.

Please contact us for a customized quotation.

Stability studies include:

  • Stability protocol and report
  • Preparation of specifications
  • Sampling
  • Management of stability programs... Show more »

We manage long-term and accelerated stability studies under GMP compliance to ensure the safety and efficacy of your candidate products.

Please contact us for a customized quotation.

Stability studies include:

  • Stability protocol and report
  • Preparation of specifications
  • Sampling
  • Management of stability programs (real-time, stressed, accelerated)
  • Management of reference standards, retention samples
  • Forced degradation studies to develop stability indicating methods
  • Stability compliance tools
  • Continuous improvement culture including KPIs to monitor performance
  • Well maintained equipment, validated and monitored storage units, emergency power back-up

We handle all aspects of sponsor stability programs. Expertise extends beyond routine sample analysis to the development and validation of stability-indicating methods. We will develop a complete package, generating a protocol according to client requirements, store samples, perform analytical testing, make stability calculations, prepare interim and final reports and maintain stability tables.

Data is maintained within our controlled database infrastructure. Additionally, the group has experience with several data management systems such as SAP and can provide input into client systems.

  • Short and long term studies
  • Continuously monitored sample storage
  • ICH stability storage conditions
  • Accelerated and forced-degradation
  • Pre-formulation stability assessment

Our experts have thorough knowledge of FDA and EMA Bioanalytical guidelines.

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SEC-MALS
Size exclusion chromatography with multiangle light scattering detectors
Starting at $500.00 per sample

Method: Size-exclusion Chromatography with Multi-Angle Light Scattering
Application: Characterization of direct molar mass and size distribution.
Services: Biophysical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note:... Show more »

Method: Size-exclusion Chromatography with Multi-Angle Light Scattering
Application: Characterization of direct molar mass and size distribution.
Services: Biophysical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Method proof-of-concept: starting from $11,200 CAD
  • Method development: starting from $11,200 CAD
  • Method qualification: starting from $16,800 CAD
  • Assay initialization cost: starting from $1000 CAD
  • Cost per sample: starting from $500 CAD
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Recombinant Protein Expression
Price on request

Biodextris offers medium scale protein manufacturing capacity capable of producing 100 - 1,000 g purified protein per lot. This capacity is an effective manufacturing platform for high quality research-grade proteins in numerous application fields:

  • Diagnostic enzymes
  • Processing enzymes
  • Environmental enzymes
    -... Show more »

Biodextris offers medium scale protein manufacturing capacity capable of producing 100 - 1,000 g purified protein per lot. This capacity is an effective manufacturing platform for high quality research-grade proteins in numerous application fields:

  • Diagnostic enzymes
  • Processing enzymes
  • Environmental enzymes
  • Research reagents
  • Target proteins for high-throughput screening activities
  • Monoclonal antibodies
  • Cytokines

Please contact us for a customized quotation.

Our team possesses a strong integrated expertise in protein production; microbial and cell culture as well as working experience with recombinant expression systems. Tagged proteins can be engineered and produced for discovery and preclinical research activities.

Quality

Our staff has several years experience in manufacturing proteins for the healthcare industry at this scale in both GMP and non-GMP environments. A strong emphasis is placed on production of high quality products in which the process is well documented and the product well characterized.

Our management team has overseen the production of dozens of proteins for use in preclinical, toxicology and clinical studies as well as several diagnostic products.

cGMP

Manufacturing of clinical study supplies under Good Manufacturing Practice guidelines is performed collaboratively with partner organizations, or your preferred provider.

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ICP-MS
Inductively Coupled Plasma Mass Spectrometry
Starting at $3,300.00 per sample

Method: Inductively-Coupled Plasma Mass Spectroscopy
Application: Trace element identification
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a... Show more »

Method: Inductively-Coupled Plasma Mass Spectroscopy
Application: Trace element identification
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Method proof-of-concept: starting from $5,600 CAD
  • Method development: NA
  • Method qualification: starting from $11,200 CAD
  • Assay initialization cost: NA
  • Cost per sample: starting from $3300 CAD
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ICAP 6000 Duo
iTEA ICAP
Lyophilization
Price on request

Biodextris offers medium scale lyophillization manufacturing capacity suitable for production of final drug product of a wide-range of protein-based products, including recombinant monoclonal antibodies, fusion proteins, virus-like particles (VLP's) and enzymes.

In-house we perform non-GMP drug product manufacturing,... Show more »

Biodextris offers medium scale lyophillization manufacturing capacity suitable for production of final drug product of a wide-range of protein-based products, including recombinant monoclonal antibodies, fusion proteins, virus-like particles (VLP's) and enzymes.

In-house we perform non-GMP drug product manufacturing, suitable for research grade material, diagnostics or pre-clinical and toxicology studies. We can lead the transfer of lyophilisation protocols to partner GMP facilites, or your preferred organisation.

Please contact us for a customized quotation.

This capacity is an effective manufacturing platform for high quality proteins in numerous application fields:
- Diagnostic enzymes
- Processing enzymes
- Research reagents
- Reference standards
- Monoclonal antibodies

Quality

Our staff has several years experience in manufacturing proteins for the healthcare industry at this scale in both GMP and non-GMP environments. A strong emphasis is placed on production of high quality products in which the process is well documented and the product well characterized.

Our management team has overseen the production of dozens of proteins for use in preclinical, toxicology and clinical studies as well as several diagnostic products.

Capacity

The following lot sizes can typically be scheduled with a short lead time for non-GMP material;

In-house lyophilization capacity per batch:

Vial volume Fill volume Number of Vials
1 mL 0.5ml 1500
Bulk 2 L 3

Larger quantities are managed with a local partner:

Volume Number of Vials
1 mL 10,000
3 mL 5,000
10 mL 2,500
50 mL 1,000
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Lyostar II
Lyomanager
Product Release Testing
Price on request

Our analytical team manages and performs quality control release and stability testing of bulk drug substance or final container drug products entering early clinical phase in compliance with GMP regulations.

Please contact us for a customized quotation.

Services

  • Provide guidance to design teams by characterizing... Show more »

Our analytical team manages and performs quality control release and stability testing of bulk drug substance or final container drug products entering early clinical phase in compliance with GMP regulations.

Please contact us for a customized quotation.

Services

  • Provide guidance to design teams by characterizing target proteins and associated variants.
  • Collaboratively develop your biologic Drug Product and Drug Product Monograph, along with specification package for all in-process characterization, release and stability programs.
  • Collaboratively develop analytical bridging strategies to demonstrate equivalence between batches, products or biosimilars.
  • Our analytical experts develop and apply cutting-edge, sensitive, selective, and robust methods for establishing the identity, strength, quality, purity, and stability of active ingredients and drug products.
  • Qualification of methods is performed following ICH guidelines and using the Analytical Development Framework.
  • Project management and CMC drafting support for regulatory submissions.

Protein Characterization Technologies

Biophysical Physiochemical Immunological
SEC MALS HPLC/UPLC ELISA
SEC FLUO SDS-PAGE SRID
FFF-MALS GC-MS Western Blot
DSC ICP
DLS cIEF
FT-IR LC-MS-MS
CD Threshold DNA quantification
AUC LAL Endotoxin testing
TEM Colorimetry
Electron tomography Peptide mapping

Fit for purpose QC testing

A substantial part of our expertise involves developing and executing customized methods to satisfy specific analytical needs.
- Development of HPLC for hemagglutinin in-process testing
- Development of HPLC methods for protein content determination
- Identification of post-translational modifications by mass spectrometry
- Amino acid substitution
- Phosphogluconoylation identification and semi-quantitation by mass spectrometry
- Pyroglutamination identification by mass spectrometry and quantitation by IEX-HPLC
- Aggregation determination by SEC-MALS

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Drug Product Characterization
Price on request

Our analytical group has extensive experience in early clinical phase assay development and product characterization, and works in compliance with GLP and GMP regulations for Quality Control release and stability testing.

Please contact us for a customized quotation.

Services

Our analytical group has extensive experience in early clinical phase assay development and product characterization, and works in compliance with GLP and GMP regulations for Quality Control release and stability testing.

Please contact us for a customized quotation.

Services

  • Provide guidance to design teams by characterizing target proteins and associated variants.
  • Ensure that all process parameters are in control.
  • Ensure that process and product impurities affecting your product quality are identified and fully understood.
  • Develop robust, qualified and validated methods to support regulatory filings for your product.

Our analytical experts develop and apply cutting-edge, sensitive, selective, and robust methods for establishing the identity, strength, quality, purity, and stability of active ingredients and drug products. Qualification of methods is performed following ICH guidelines and using the Analytical Development Framework.

Protein Characterization Technologies

Biophysical Physiochemical Immunological
SEC MALS HPLC/UPLC ELISA
SEC FLUO SDS-PAGE SRID
FFF-MALS GC-MS Western Blot
DSC ICP
DLS cIEF
FT-IR LC-MS-MS
CD Threshold DNA quantification
AUC LAL Endotoxin testing
TEM Colorimetry
Electron tomography Peptide mapping

Fit for Purpose Method Development

A substantial part of our expertise involves developing customized methods to satisfy specific analytical needs.

  • Development of HPLC for hemagglutinin in-process testing
  • Development of HPLC methods for protein content determination
  • Identification of post-translational modifications by mass spectrometry
  • Amino acid substitution
  • Phosphogluconoylation identification and semi-quantitation by mass spectrometry
  • Pyroglutamination identification by mass spectrometry and quantitation by IEX-HPLC
  • Aggregation determination by SEC-MALS
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Bioprocess Development and Scale-Up
Price on request

Upstream Fermentation Process Development - Drug Substance Process Development

Our group has extensive experience in developing robust microbial fermentation processes targeting high product yields and preferred product attributes. Development projects are conducted in 15L fermenters, digitally interfaced for continuous... Show more »

Upstream Fermentation Process Development - Drug Substance Process Development

Our group has extensive experience in developing robust microbial fermentation processes targeting high product yields and preferred product attributes. Development projects are conducted in 15L fermenters, digitally interfaced for continuous acquisition of relevant online process control data:
Temperature, pH, agitation, airflow, pressure, dissolved oxygen, exhaust gas (O2/CO2) and nutrient feeds can all be monitored and/or controlled under batch or fed-batch conditions

Services

  • Media evaluation in flask or bioreactor
  • Host strain evaluation in flask or bioreactor
  • Scale-up from Laboratory to Pilot-scale.
  • Development of batch or fed-batch protocols.
  • Process improvement or optimization strategies.
  • Comprehensive upstream development package.

Capabilities

  • 15 L bioreactors
  • High pressure cell disruption
  • Fixed-angle centrifugation
  • Tangential Flow Filtration
  • Upstream Analytics Include
    • Microbial viability, purity and identity
    • Biomass, metabolite & nutrient analysis
    • Yield and quality by electrophoresis and HPLC

Downstream Purification Development

We have extensive experience in the development and implementation of purification processes for manufacture of a wide range of proteins. These include recombinant monoclonal antibodies, fusion proteins, enzymes and other proteins.

To ensure the development of an integrated process, and to minimize the development timeline, purification development activities are performed in parallel with fermentation and assay development activities. A target specification for the product is first defined with the customer, and the downstream process is designed to meet this specification.

Services

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

Capabilities

  • AKTA Avant and Pilot systems
  • Ion exchange chromatography
  • Hydrophobic interaction chromatography
  • Reverse phase chromatography
  • Size exclusion chromatography
  • Tangential flow filtration
  • Sterile filtration
  • Process analytics
    • Differential ccanning colorimetry
    • HPLC
    • Mass spectroscopy
    • Asymmetric Field Flow Fractionation

Please contact us for a customized quotation.

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Radial Immunodiffusion Assay
Single Radial Immunodiffusion
Starting at $500.00 per sample

Method: Single Radial Immunodiffusion
Application: Hemagglutinin potency assay
Services: Immunological assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized... Show more »

Method: Single Radial Immunodiffusion
Application: Hemagglutinin potency assay
Services: Immunological assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Method proof-of-concept: starting from $11,200 CAD
  • Method development: starting from $11,200 CAD
  • Method qualification: starting from $16,800 CAD
  • QC assay initialization cost: starting from $3,000 CAD
  • QC assay cost per sample: starting from $500 CAD
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pH Measurement
Starting at $75.00 per sample

Method: pH
Application: pH determination (acidity/alkalinity)
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

Method: pH
Application: pH determination (acidity/alkalinity)
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Method proof-of-concept: NA
  • Method development: NA
  • Method qualification: NA
  • Assay initialization cost: NA
  • Cost per sample: starting from $75 CAD
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Colorimetry
Starting at $75.00 per sample

Method: Colorimetry
Application: Color determination
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

Method: Colorimetry
Application: Color determination
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Method proof-of-concept: NA
  • Method development: NA
  • Method qualification: starting from $5,600 CAD
  • Assay initialization cost: starting from $400 CAD
  • Cost per sample: starting from $75 CAD
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Ultra Scan VIS
Hunterlab
EasyMatch QC
HunterLab
Endotoxin Testing
Starting at $800.00 per sample

Method: Endotoxin by Limulus amebocyte lysate assay
Application: Quantification of residual LPS or endotoxin
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please... Show more »

Method: Endotoxin by Limulus amebocyte lysate assay
Application: Quantification of residual LPS or endotoxin
Services: Physiochemical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Method proof-of-concept: starting from $11,200 CAD
  • Method development: starting from $11,200 CAD
  • Method qualification: starting from $16,800 CAD
  • Assay initialization cost: starting from $1000 CAD
  • Cost per sample: starting from $800 CAD
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Dynamic Light Scattering
Starting at $300.00 per sample

Method: Dynamic Light scattering
Application: Particle size and size distribution determination
Services: Biophysical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a... Show more »

Method: Dynamic Light scattering
Application: Particle size and size distribution determination
Services: Biophysical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Method proof-of-concept: starting from $2,800 CAD
  • Method development: NA
  • Method qualification: starting from $2,800 CAD
  • QC assay initialization cost: starting from $1200 CAD
  • QC assay cost per sample: starting from $300 CAD
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Zetasizer Nano ZS
Malvern
DTS Nano
Malvern
FFF-MALS
Field-flow fractionation with multi-angle light scattering
Starting at $500.00 per sample

Method: Field Flow Fractionation with Multi-Angle Light Scattering
Application: Molar Mass and size distribution determination
Services: Biophysical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only... Show more »

Method: Field Flow Fractionation with Multi-Angle Light Scattering
Application: Molar Mass and size distribution determination
Services: Biophysical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Method proof-of-concept: starting from $5,600 CAD
  • Method development: starting from $11,200 CAD
  • Method qualification: starting from $11,200 CAD
  • Assay initialization cost: NA
  • Cost per sample: starting from $2000 CAD
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Agilent
Chemstation Astra
Fluorescence SEC
Fluorescence-Detection Size-Exclusion Chromatography
Starting at $500.00 per sample

Method: Fluorescence-detection Size-exclusion Chromatography
Application: Determination of aggregation.
Services: Biophysical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for... Show more »

Method: Fluorescence-detection Size-exclusion Chromatography
Application: Determination of aggregation.
Services: Biophysical assay development, qualification and execution for QC release and stability.
Compliance: GMP assay qualification and QC release/stability testing.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Method proof-of-concept: starting from $11,200 CAD
  • Method development: starting from $11,200 CAD
  • Method qualification: starting from $16,800 CAD
  • Assay initialization cost: starting from $1000 CAD
  • Cost per sample: starting from $500 CAD
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Waters
Empower
Microbial Fermentation and Bioprocessing
Starting at $4,600.00 per run

Microbial fermentation for production of whole-cell or cell-extracts is performed at 10-15L scale.

Note: Pricing is a guide only - please contact us for a customized quotation.

Non-GMP production, suitable for research grade material, diagnostics or pre-clinical studies.
Batch or fed-batch protocols.
Inactivation... Show more »

Microbial fermentation for production of whole-cell or cell-extracts is performed at 10-15L scale.

Note: Pricing is a guide only - please contact us for a customized quotation.

Non-GMP production, suitable for research grade material, diagnostics or pre-clinical studies.
Batch or fed-batch protocols.
Inactivation protocols.
Full monitoring and control of on-line data, including: Temperature, pH, agitation, airflow, pressure, dissolved oxygen, exhaust gas (O2/CO2) and nutrient feeding.
Off-line monitoring of cell density (OD), viability (CFU), purity, nutrients/metabolites
Harvest cell-paste stored in frozen 1L aliquots for convenient downstream processing.

Starting from $4600 CAD per fermentation batch.

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Sartorius Biostat-Cplus
MFCS
Drug Product Manufacturing
Starting at $4,600.00 per run

Production of formulated liquid or lyophilized drug product of a wide-range of protein-based products, including recombinant monoclonal antibodies, fusion proteins, virus-like particles (VLP's) and enzymes.

Note: Pricing is a guide only - please contact us for a customized quotation.

Non-GMP drug product manufacturing,... Show more »

Production of formulated liquid or lyophilized drug product of a wide-range of protein-based products, including recombinant monoclonal antibodies, fusion proteins, virus-like particles (VLP's) and enzymes.

Note: Pricing is a guide only - please contact us for a customized quotation.

Non-GMP drug product manufacturing, suitable for research grade material, diagnostics or pre-clinical and toxicology studies.
Production of liquid or lyophilized drug product vials: up to 1500 x 3ml glass vials (0.5 ml fill volume) per batch.
Production of lyophilized bulk drug product up to 3x 2L per batch.
Colorimetry, particle size, turbidometry, immunological characterization.

Liquid or lyophilized drug product batches starting at $4,600 CAD

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Malvern VP-DSC
Lyostar II
Lyomanager
Hach turbidimeter
Turbidimeter
Mastersizer 2000
Malvern Mastersizer 2000
Sartorius WDS400 Coulometer
WDS400 Coulometer
Atlas Suncool
Atlas CPS
Antek 9000N
Antek Nitrogen Detector
Mastersizer
Antek
Nephelostar
Protein Purification
Starting at $21,000.00 per run

Execution of downstream purification protocol for a wide-range of protein-based products, including recombinant monoclonal antibodies, fusion proteins, virus-like particles (VLP's) and enzymes.

Note: Pricing is a guide only - please contact us for a customized quotation.

Non-GMP drug substance production, suitable for... Show more »

Execution of downstream purification protocol for a wide-range of protein-based products, including recombinant monoclonal antibodies, fusion proteins, virus-like particles (VLP's) and enzymes.

Note: Pricing is a guide only - please contact us for a customized quotation.

Non-GMP drug substance production, suitable for research grade material, diagnostics or pre-clinical studies.
Cell disruption, homegenate clarification, chromotography (IEX, HIC, RP, SEC), Tangential Flow-filtration (MF/UF), sterile filtration.
In-process characterization: SDS-PAGE (Coomassie/Silver), Western Blot, HPLC, DSC, MS

Downstream purification batches starting at $21,000 CAD

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Amersham Biosciences AKTApilot
Beckman Coulter Optima Ultracentrifuge L-100 XP
Qubit 2.0 fluorometer
UNICORN
Molecular Devices Spectramax
Malvern VP-DSC
AKTA Pilot
AKTA Avant
GE AKTA Avant
Centrifuge Avanti J20
Beckman Coulter Avanti J20 XP Centrifuge
Centrifuge Optima L-100 XP
IKA Ultra-Turrax Homogenizer
GEA Niro-Soavi Panda 2K
Panda 2K
GE Unicorn
Millipore TFF system
Bacterial Protein Expression
Starting at $4,600.00 per run

Microbial fermentation for recombinant protein production is performed at 10-15L scale.

Note: Pricing is a guide only - please contact us for a customized quotation.

Non-GMP production, suitable for research grade material, diagnostics or pre-clinical studies.
Batch or fed-batch protocols.
Full monitoring and control of... Show more »

Microbial fermentation for recombinant protein production is performed at 10-15L scale.

Note: Pricing is a guide only - please contact us for a customized quotation.

Non-GMP production, suitable for research grade material, diagnostics or pre-clinical studies.
Batch or fed-batch protocols.
Full monitoring and control of on-line data, including: Temperature, pH, agitation, airflow, pressure, dissolved oxygen, exhaust gas (O2/CO2) and nutrient feeding.
Off-line monitoring of cell density (OD), viability (CFU), purity, plasmid retention, nutrients/metabolites, product yield and quality.
Harvest cell-paste stored in frozen 1L aliquots for convenient downstream processing.

Starting from $4600 CAD per fermentation batch.

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Yeast
E. coli
Bacteria
Sartorius Biostat-Cplus
MFCS
Escherichia coli
Pichia pastoris
Saccharomyces cerevisiae
Protein Purification Process Development
Starting at $145,000.00 per unit

Full-service process development of downstream purification protocols for a wide-range of protein-based products, including recombinant monoclonal antibodies, fusion proteins, virus-like particles (VLP's) and enzymes.

Note: Pricing is a guide only - please contact us for a customized quotation.

Final downstream process... Show more »

Full-service process development of downstream purification protocols for a wide-range of protein-based products, including recombinant monoclonal antibodies, fusion proteins, virus-like particles (VLP's) and enzymes.

Note: Pricing is a guide only - please contact us for a customized quotation.

Final downstream process ready for transfer to phase I/II GMP production partner.
Targeting high product yields and preferred product attributes.
Includes complete documentation package, process development reports and CMC draft support.

Complete downstream process development package starting at $145,000 CAD

  • Cell disruption protocol development: starting from $9,300 CAD.
  • Chromotography strategy development (IEX, HIC, RP SEC): starting from $75,000
  • Diafiltration/Ultrafiltration development: starting from $18,700 CAD.
  • Sterile Filtration development (drug substance): starting from $4,600 CAD
  • In-process analytical tool development (eg. DSC, HPLC, MS, FFF): starting from $37,500 CAD
  • Accelerated stability, stress-testing (drug substance): starting from $9,300
« Show less
Amersham Biosciences AKTApilot
Beckman Coulter Optima Ultracentrifuge L-100 XP
Qubit 2.0 fluorometer
UNICORN
Molecular Devices Spectramax
Malvern VP-DSC
AKTA Pilot
AKTA Avant
GE AKTA Avant
Centrifuge Avanti J20
Beckman Coulter Avanti J20 XP Centrifuge
Centrifuge Optima L-100 XP
IKA Ultra-Turrax Homogenizer
GEA Niro-Soavi Panda 2K
Panda 2K
GE Unicorn
Microbial Process Development
Starting at $110,000.00 per unit

Full-service process development of upstream microbial fermentation protocols, batch or fed-batch.

Note: Pricing is a guide only - please contact us for a customized quotation.

Final upstream process ready for transfer to phase I/II GMP production partner.
Targeting high product yields and preferred product... Show more »

Full-service process development of upstream microbial fermentation protocols, batch or fed-batch.

Note: Pricing is a guide only - please contact us for a customized quotation.

Final upstream process ready for transfer to phase I/II GMP production partner.
Targeting high product yields and preferred product attributes.
Full monitoring and control of on-line data, including: Temperature, pH, agitation, airflow, pressure, dissolved oxygen, exhaust gas (O2/CO2) and nutrient feeding.
Offline sample analysis for microbial and product (eg. recombinant protein) characteristics.
Includes complete documentation package, process development reports and CMC draft support.

Complete upstream process development package starting at $117,000 CAD

  • Pre-culture (flask) protocol development: starting from $14,000 CAD.
  • Media development: starting from $18,700 CAD.
  • In-process analytical tool development: starting from $9,300 CAD
  • Fermentation process development (batch/fed-batch): starting from $75,000 CAD.
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Yeast
E. coli
Bacteria
Sartorius Biostat-Cplus
MFCS
Escherichia coli
Pichia pastoris
Saccharomyces cerevisiae
Microbial Cell Bank Production
Starting at $4,000.00 per prep

Preparation and characterization of non-GMP microbial Parent Master and Working seed banks.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Parent Seed (10-20 vials) starting from $4000 CAD
  • Master Seed (100-200 vials) starting from $5500 CAD
  • Working Seed (100-500 vials) starting from $5500 CAD

Preparation and characterization of non-GMP microbial Parent Master and Working seed banks.

Note: Pricing is a guide only - please contact us for a customized quotation.

  • Parent Seed (10-20 vials) starting from $4000 CAD
  • Master Seed (100-200 vials) starting from $5500 CAD
  • Working Seed (100-500 vials) starting from $5500 CAD
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Yeast
E. coli
Bacteria
Escherichia coli
Pichia pastoris
Saccharomyces cerevisiae
Biologic Formulation
Starting at $168,000.00 per unit

Full-service formulation development of protein-based biologic drug products, targeting product stability and activity for the selected administration route.

Note: Pricing is a guide only - please contact us for a customized quotation.

Liquid or lyophilized formulations are optimized for appearance, reconstitution and... Show more »

Full-service formulation development of protein-based biologic drug products, targeting product stability and activity for the selected administration route.

Note: Pricing is a guide only - please contact us for a customized quotation.

Liquid or lyophilized formulations are optimized for appearance, reconstitution and stability.
Includes complete documentation package, process development reports and CMC draft support.

Full formulation development package starting from $168,000 CAD.

  • Pre-formulation compatibility and stress-testing: starting from $37,500 CAD
  • Formulation development, including excipient screening, lyophilisation cycle: starting from $75,000 CAD
  • Short-term stability studies: starting from $37,500 CAD
  • Sterile filtration (drug product): starting from $18,700 CAD

Our team has extensive expertise in the development of both liquid and lyophilized formulations.

Services
- Excipient screening
- Protein combatability studies
- Stress testing
- Short-term stability studies

Capabilities
- Liquid formulation
- Lyophillized formulation
- Spray dried powder
- Multi-component presentations
- Process Analytics
- Colorimetry
- Particle Size - Malvern Technologies
- Turbidometry
- Immunological characterization

« Show less
Malvern VP-DSC
Lyostar II
Lyomanager
Hach turbidimeter
Turbidimeter
Mastersizer 2000
Malvern Mastersizer 2000
Sartorius WDS400 Coulometer
WDS400 Coulometer
Atlas Suncool
Atlas CPS
Antek 9000N
Antek Nitrogen Detector
Mastersizer
Antek
Scientific Consulting
Price on request
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Purification Services
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Antibody Services
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Electrophoresis
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Product Development & Testing
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Manufacturing
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Nucleic Acid Services
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Calorimetry
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Mass Spectrometry
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Microbiology, Virology, and Parasitology
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Size Exclusion Chromatography
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Physical Analysis Methods
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Protein Quantification
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Project Management & Consulting Services
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Engineering & Devices
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Chromatography
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Spectroscopy
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Biology
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Other Mass Spectrometry Methods
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Protein Purification and Quantification
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Cells and Tissues
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Process Consulting
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Bacterial Culture
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DNA
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Liquid Chromatography
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Protein Services
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Liquid Chromatography Coupled Mass Spectrometry Methods
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Protein Expression Visualization
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Gel Electrophoresis
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Chemistry and Materials
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Protein Expression
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Scattering Techniques
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Testing of Cell Lines
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Biochemistry & Molecular Biology
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Analytical Chemistry Services
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Formulation & Manufacturing
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Imaging & Spectroscopy
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2016-01-28 06:45:37 +0800

Biodextris offers an expertise on process development, fermentation, purification, analytical that PAIRimmune members deal with since few years and we always been satisfied of their service. We recommend strongly their business.

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