Expertise & Services

disciplined agilityassay development specialty testing

150+ Dedicated scientists and analysts

10+ years In bioanalytical & immunogenicity

15+ years In vaccines and immunotherapeutics

20+ years In preclinical models and immune read-outs

30+ years In biomarkers

100+ IND filings of new molecular entities

250,000+ Results generated per year

150+ Validated biomarkers

About UsWith unrivaled expertise in immunology on both sides of the client/CRO relationship, we are a leading provider of assay development and specialty laboratory testing.

Our versatile team of scientists, working with our advanced technology platforms, were instrumental in the development qualification, validation, and large-scale sample testing of assays that supported the FDA filing of almost 100 new molecular entities, including blockbuster vaccines and soluble large molecules.

GCP/GLP  GCLP/GCP/GLP

Protein Sciences

Immunochemistry

Viral and Bacterial Functional assays

Cellular Immunology

Assay Transfer, Development, Quali�cation, Validation

High Throughput Sample Testing

Development, Transfer, Validation

Sample Analysis

Pharmacokinetic

Immunogenicity - ADA

Nab/Cell-Based Assays

Fit-For-Purpose Biomarkers

Reagent Characterization; Assay Performance Monitoring; Client-Centric Service O�ering; Project Management; Quality Systems

Bioanalytical

LARGE MOLECULE SPECIALISTS

Non GLP

 In Vivo Animal Models

E�cacy

Immunogenicity

Reactogenicity

CAP/CLIA

Menu of 150 Biomarkers

In�ammatory Cytokine and Chemokine

Hormones

Organ Injury Panels (liver, kidney)

Angiogenesis Biomarkers

Tumor Antigens

Preclinical Vaccines Biomarkers

Focus Area

Vaccines Bioanalytical

Immunology Focus

Long industry experience in the development, qualification and validation of complex immunological assays. High throughout sample testing to support vaccine development.

Extensive experience in immunogenicity testing and in the fit-for-purpose biomarker development. Biomarker panels covering autoimmunity, oncology, and metabolic disorders as well as organ injuries.

BacteriologyHaemophilus influenzae, Neisseria meningitidis, Streptococcus pneumoniae, Bordetella pertussis, Corynebacterium diphtheriae, Clostridium tetani, Staphylococcus aureus, Streptococcus agalactiae (GBS), Escherichia coli, Shigella spp., Clostridium difficile, Salmonella typhimurium

VirologySeasonal & Pandemic Influenza, Respiratory Syncytial virus, Rhinovirus, Chikungunya, Zika, Dengue, Malaria, Yellow Fever, Human Papilloma Virus, Adenovirus, Measles, Mumps, Rubella, Varicella Zoster, Lymphocytic Choriomeningitis Mammarenavirus (LCMV), Vaccinia, Cytomegalovirus, Herpes, Hepatitis B, Rotavirus

Autoimmune DisordersRheumatoid Arthritis, Inflammatory Bowel Diseases, Skin Diseases, Metabolic Disorders, Brain and Gut Axis (Microbiome), Inflammation and Immunity

OncologySolid Tumors and Blood Malignancies: Tumor Specific Antigens, Immune Checkpoint-Inhibitors, CAR-T Cells, Therapeutic Cancer Vaccines

We have deep expertise in the disciplined field of vaccines, large molecule bioanalysis, and biomarkers to support biologics innovations from preclinical to post-registration studies.

Translational SciencesSupport for preclinical and clinical development of vaccines and large molecules.

Our team has an extensive Pharma and Biotech track record developing/transferring, qualifying and validating tests ranging from preclinical to clinical Phase I – IV.

Nexelis offers multiple automated systems for high-throughput analysis capabilities to support projects from early development through large clinical trials.

Nexelis offers a key asset by having multiple automated systems for high-throughput analysis capable of generating over 250K results annually to support early development through large clinical trials.

High Throughput Testing

High Throughput Sample Testing

Immunological Assay Development, Quali�cation and Validation

discovery preclinical phase I phase II phase III market phase IV

Fit-For-Purpose Biomarker Assays

Bioanalytical Assays

Antigen Design, Expression, Puri�cation and Characterization

In Vivo E­cacy Models

Identi�cation of Key Sta� at Client Facility for Assay Transfer / Quali�cation(Knowledge Transfer)

Gap Analysis to Assess the Level of Di�erence Between Both Laboratories(e.g. Know-How, Experimental Conditions, Equipment, Reagents, Documentation)

Minor Di�erence – Comparative TestingMajor Di�erence – Partial or Full Re-Development, Re-Quali�cation, Re-Validation as Required

Assay Transfer From Sponsor to UsVisit of Client to Observe and Audit

Assay Transfer Protocol

Assay Transfer Report

Customized Development Assay development/transfer, qualification and validation based on your specific needs, in order to deliver stable and robust methods for reliable results.

Assay Development and Technology Transfer

Nexelis is a leading partner in assay development and technology transfer throughout its multiple platforms to support large molecules and vaccines preclinical and clinical development. Our team has a wealth of Pharma experience developing and troubleshooting complex assays that meet regulatory agencies requirements.

We work in close collaboration with our partners to transfer immunological assays, to optimize existing assays to be aligned with regulatory requirements, and to increase the assay throughput, while monitoring the assay performance throughout the clinical trial testing.

Our Services

Protein Sciences

Molecular Biology

Protein Expression

Protein Purification

Protein Characterization

Preclinical

Animal Study Design

In vivo Study Approaches

Study Readouts

Immunochemistry assays

Immune Response Quantification

Single and Multiplexed ELISA, MSD, AlphaLISA

Viral Functional Assays

Plaque Reduction Neutralization Test (PRNT) and micro PRNT

Neutralization and Microneutralization

Pseudo-particle Neutralization

Hemagglutination Inhibition (HAI)

Bacterial Functional Assays

Serum Bactericidal (SBA)

Opsonophagocytosis (OPA)

Qualification of Human and Rabbit Serum Complement

Cellular Mediated Immunology

Flow Cytometry

ELISpot

Bioanalytical

Pharmacokinetic (PK)

Immunogenicity-ADA

Fit-For-Purpose Biomarkers

Biomarkers

Menu of over 150 biomarkers: inflammation and immunology, oncology, cardiovascular/metabolic diseases, organ injuries and nutritional health, etc.

Facilities

Seattle21,000 sq.ft. of laboratories and offices

State-of-the-art equipment to support bioanalytical services: e.g. Singulex, VersaMax, MSD, EnVision, Synergy H4

Laval45,000 sq.ft. of state-of-the-art laboratories and offices

State-of-the-art equipment to support vaccines and bioanalytical services: e.g. ÄKTA, MSD, ELISpot, Flow Cytometry, AlphaLisa

Unique high-throughput capabilities: e.g. TECAN, Image Analyzers

nexelis.com

Canada

525 Cartier West Blvd Laval QC H7V 3S8

1 450 239-1605

USA

645 Elliott Avenue WestSuite 300 Seattle WA 98119

1 206 298-0068