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Altasciences

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Laval, CA

About Altasciences

Altasciences is a full service CRO that provides preclinical and clinical bioanalytical solutions (and more) to an international customer base of biopharmaceutical companies. All our services encompass both large and small molecules, and are fully compliant with global regulatory requirements.

We have bioanalytical Principal Investigators on staff, and apply all our expertise to every project, large or small. We have a dedicated Methods Development Team and space, and a list of over 600 validated, proprietary assays.

Altasciences’ full-service offering includes program management, preclinical safety testing, clinical pharmacology services, medical writing, biostatistics, data management, and manufacturing and analytical services for small molecules; all tailored to your specific research requirements. We are an award-winning, forward-thinking, mid-size, early phase contract research organization with a unique company focus on supporting drug development from lead candidate selection to proof of concept, with over 25 years of industry experience.

Our Services (63)


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Biospecimens

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qPCR Assay Design

Quantitative PCR experimental design
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Antibody Screening

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Tissue-Based Assays

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In vitro Immunotoxicity Testing

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Other Mass Spectrometry Methods

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IND-Enabling Studies

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MSD Assays

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Cell Viability & Proliferation Assays

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Antibody/Antigen Detection Based Testing

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Human Immune Cell Assays

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Specialized Cell-Based Assays

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Custom Cell-Based Assay Development

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Clinical Biomarkers

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Small Molecule Bioanalysis

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Large Molecule Bioanalysis

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Flow Cytometry Data Analysis

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Flow Cytometry

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Cytokine Analysis

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In vivo PK/PD Studies

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Immunohistochemistry (IHC)

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Clinical and Anatomic Pathology

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Anatomic Pathology

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Safety Pharmacology

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Clinical Bioavailability/Bioequivalence Studies

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Over 600 validated assays available for BA/BE studies


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Dose Range Finding (DRF) Studies

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Preclinical Histology

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Preclinical Study Design

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LC-MS

Liquid Chromatography-Coupled Mass Spectrometry
Price on request
  • LCMS services include small molecules including labile metabolites, endogenous compounds
  • Non-GLP discovery analyses
  • Method validation consistent with EMEA and FDA guidances
  • Over 600 proprietary assays developed and validated for Altasciences’ sponsor use
  • LCMS Hybrid approach (Immunocapture/Immunoaffinity) for large molecule analysis for intact proteins, biomarkers and peptides (includes pegylated, ADC, antibodies)
  • Over 34 LCMS instruments ranging from 3000, 5000, 5500, 5600, 6500, 6600 and ThermoFisher Q-Exactive
  • Expertise in MITRA® Volumetric Absorptive Microsampling for small and large molecules with over 15,000 study samples analyzed to support clinical trials to date


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Ligand Binding Assays

Price on request

Immunogenicity assays:

  • ADA: screening, confirmatory and titration
  • nAb by non-cell based and cell-based assays
  • Quantification methods using various platforms
  • Hybridization ELISA/ECLIA of various types (ligation, dual hybridization)
  • Functional cell-based assays
  • Antibody response (TDAR)
  • Biomarkers
  • Cell lineage and functional immunophenotyping by flow cytometry
  • PCR analysis (Droplet digital PCR, Quantitative PCR)
  • Cytokine/Chemokine Analysis
  • Electrochemiluminescence (ECL)

ADA anti-drug antibodies (ADA) Hybridization Assay Cell-based assays Custom Cell-Based Assay Development Specialized Cell-Based Assays Show 6 more tags Show less

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In vitro Immunogenicity Assays

Price on request
  • Direct binding ELISA using a multimode plate reader.
  • Bridging ELISA and electrochemiluminescence (ECL) assays.
  • SQI Diagnostics’ Ig_PLEX™ multiplexing technology for ADA screening, isotyping and quantitation.

ELISA ligand binding assays (ELISA and MSD)

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Luminex Multiplex Assays

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Biomarkers

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  • Fit-for-purpose approach
  • Method validation
  • Discovery, preclinical, and early phase (to phase IV) clinical biomarker analysis
  • Capabilities to measure single analyte or multiple analytes
  • Multiple platforms including MSD and ELISA
  • LC-MS/MS biomarker capabilities


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ELISA

Enzyme-linked immunosorbent assay
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Phase I Clinical Trials

Price on request

Database of over 365,000 healthy, patient and special populations

Comprehensive full service Phase I/IIa offering:

  • High quality trial conduct
  • Therapeutic class expertise
  • Accelerated study-start and report timelines.

Customized study designs include (among others) :

  • Efficacy/POC studies
  • First in Human
  • SAD and MAD
  • Adaptive Integrated Clinical Designs (SAD/MAD)


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T Cell Activation and Proliferation Assays

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Bioanalytical Assays

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  • Scientific excellence
  • Uncompromised quality
  • Adherence to timelines
  • GLP-compliant bioanalytical facility equipped with next generation instrumentation
  • Expertise in protein and peptide quantitation

Dedicated method development group and space ensures a straightforward and compliant submission for any country

Our expertise, combined with our state-of-the-art instrumentation, allows us to achieve: 

  • Extremely low LLOQ
  • Large dynamic ranges
  • Analysis of multiple metabolites
  • Analysis from various matrices and species
  • Quick method development using strict criteria
  • Successful method transfer or adaptation

Our Bioanalysis Group is responsible for method validation and study sample analysis, with:

  • Experience working with different matrices and species
  • Experience with complex multi-sites and Phase IIa/III studies
  • Highly trained employees on GLP and international regulations
  • Flexibility and quick timelines using on-going Quality Assurance
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We perform assays for hundreds of thousands of samples each year, many for multiple analytes and comprising parent drug and several metabolites in one single assay. Sample analysis is performed for projects carried out in our own clinics as well as for external projects (from preclinical to Phase I-IV).


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Medical Writing

Price on request

Dedicated team of professional medical writers provides a complete writing service, as stand alone or part of a complete program:

  • Protocols
  • Protocol amendments
  • Informed Consent Forms
  • Clinical study reports
  • Pharmacokinetic reports
  • Biostatistical reports
  • Bioanalytical reports
  • Safety reports
  • Any other type of document necessary for a successful clinical trial.

We can also offer general medical communications such as publications, posters, abstracts, and promotional and educational material.

All documents are tailored to your individual requirements and produced to the applicable regulatory guidelines.


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NAb Assays

Neutralizing Antibody Assays
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Regulatory Affairs Services

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Scientific & Regulatory Affairs Department assures the goal of your study meets the requirements of corresponding authorities.

In addition to protocol development, the Scientific & Regulatory Affairs Department handles the Clinical Trial Applications (CTAs), ensuring adherence to legislative demands. The same staff attends Ethics Committee meetings in order to rapidly resolve questions, thereby reducing the approval time of each project.

The department provides custom clinical trial reports carefully prepared according to regional guidelines of the following organisations:

  • US Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER)/Office of Generic Drugs (OGD)
  • Health Products and Food Branch (HPFB)/Therapeutic Products Directorate (Health Canada)
  • European Medicines Agency (EMA)
  • International Conference on Harmonisation (ICH)
  • Therapeutic Goods Administration (TGA)

Past projects have been reviewed and approved by major authorities, and successfully audited by the following agencies:

  • US Food and Drug Administration (FDA) (USA)
  • Therapeutic Products Directorate (Health Canada)
  • Agência Nacional de Vigilância Sanitária (ANVISA) (Brazil)
  • Agence nationale de sécurité du médicament et des produits de santé (ANSM) (France)
  • Medicines and Healthcare products Regulatory Agency (MHRA) (United Kingdom)
  • Austrian Agency for Health and Food Safety (AGES) (Austria)
  • Department of Medical Sciences, Ministry of Public Health (Thailand)
  • Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) (Spain)


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Biostatistics & Bioinformatics

Price on request

Determination of ADA cutpoints


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Oligonucleotides

Price on request
  • Hybridization assays
  • Ligand Binding
  • Mass Spectrometry Triple quad and HRMS capabilities
  • UHPLC, micro and nano flow capabilities


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Mass Spectrometry

Price on request
  • Triple quad and HRMS capabilities
  • Support hybrid LC/MS biotherapeutic analysis
  • UHPLC, micro and nano flow capabilities


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Antibody-Drug Conjugate (ADC) Analysis

Price on request

State of the art labs with Mass Spec and Ligand Binding platforms


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Functional & Cell Type Specific Assays

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Immunoassays

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Immunoassays Services


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Cell-Based Assays

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Purpose built cell culture lab, extensive scientific expertise


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In vitro ADME/DMPK Studies

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
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Drug Discovery

Price on request

Drug Discovery Services


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Immune Cell Assays

Price on request

Immune Cell Assays Services


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Protein Quantification

Price on request
  • Mass Spectrometry
  • Triple quad and HRMS
  • UHPLC, micro and nano flow capabilities
  • Experience in biotherapeutic quantitative analysis
  • Screening, qualified and validated assays


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Biochemistry & Molecular Biology

Price on request

qPCR


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Clinical Trials, Consulting, and Management

Price on request

Clinical Trials, Consulting, and Management Services


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Clinical Research

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Clinical Research Services


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Bioanalysis

Price on request
  • Scientific excellence
  • Uncompromised quality
  • Adherence to timelines

GLP-compliant bioanalytical facility equipped with next generation instrumentation Expertise in protein and peptide quantitation

Dedicated method development group and space ensures a straightforward and compliant submission for any country

Our expertise, combined with our state-of-the-art instrumentation, allows us to achieve:

  • Extremely low LLOQ
  • Large dynamic ranges
  • Analysis of multiple metabolites
  • Analysis from various matrices and species
  • Quick method development using strict criteria
  • Successful method transfer or adaptation

Our Bioanalysis Group is responsible for method validation and study sample analysis, with:

  • Experience working with different matrices and species
  • Experience with complex multi-sites and Phase IIa/III studies
  • Highly trained employees on GLP and international regulations
  • Flexibility and quick timelines using on-going Quality Assurance

We perform assays for hundreds of thousands of samples each year, many for multiple analytes and comprising parent drug and several metabolites in one single assay. Sample analysis is performed for projects carried out in our own clinics as well as for external projects (from preclinical to Phase I-IV).


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Pharmacology

Price on request

Pharmacology Services


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Pharmacology & Toxicology

Price on request

Pharmacology & Toxicology Services


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Drug Discovery & Development

Price on request

Drug Discovery & Development Services


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Data Analysis

Price on request

Data Analysis Services


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Hybrid LBA/LC-MS Assays

Price on request

Scientific expertise and capabilities: Triple quad and HRMS Kingfisher flex for automated workflows


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Data Management

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Mass Spectrometry Data Analysis

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