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Discovery

Immunoassays & Immunology

Our Immunoassay / Inflammation platform allows for the multiplex measurement of Panels for Oncology, Immunology/Inflammation (Cytokines / Chemokines), Cardiology, Neurology, Obesity, Diabetes and Metabolic disorders. We have long-term experience in de novo assay-development of ELISA  and  Meso Scale Discovery (MSD) assays. And can support you with off the shelf, costumer fit-for-purpose assays and flexible personalized (U-PLEX) and validated (V-PLEX) Mesoscale assays

Clinical Phase 2

Immunoassay and Immunology

To fully support clinical studies in patients be it from a single center study to multi-center clinical trials we offer the full palette of immunoassay and immunology services to afford a streamlined pathway in the efficient analysis of samples with a cost effective approach.

Immunoassay

Immunoassay services focus on ligand binding methodologies to include absorbance, fluorescence, and luminescence as well as electrochemiluminescence. We can offer both off the shelf commercial assays for routine parameters as well as assays that are custom developed in our GLP laboratory to support your specific needs.  In addition to assays run in matrices from normal healthy subjects we routinely run assays in disease patient matrices to support later stage clinical trials. This includes assays from patients with infectious diseases that are analysed in conjunction with our BSL2 laboratory certification. We also have a variety of external providers able to supply specialty disease state matrix for use in assays as needed.  

Sample analysis can range from only the single sample to the thousands often associated with late stage clinical trials as NUVISAN has the depth, breath, and experience to accommodate the analysis of samples depending on your needs.

As an added service we can also provide clinical supplies as well as logistics support for the collection and shipment of samples to our laboratories so as to offer a turn-key approach to sample analysis and the optimization of clinical study conduct.

Immunology

Immunology services include immunogenicity testing for anti-drug antibodies (ADA/Nab) using a combination of ligand binding techniques and flow cytometry assays as well as a variety of cell-based assays to assess a broad range of immune parameters.  This includes functional testing of immune cells for mode of action analysis as well as immune monitoring of clinical trials

To afford shipment of samples from clinical sites for selected cell-based assays we also have experience in the development and validation of systems to stabilize and preserve cells so as to allow multi-day shipments with receipt of viable samples for subsequent analysis.

We can also offer blood-borne cell preparations from freshly isolated cells or cells stimulated or treated otherwise in vitro. Cell preparations using blood samples collected from healthy normal subjects and our own in-house clinic located at the same site as the laboratory assure that we work with the freshest material possible.

Mass Spectrometry (LC/MS)

Our European centered LC-MS/MS laboratories fully support the analysis of samples from clinical studies in patients from single center studies to international multi-center clinical trials.

Our LC-MS/MS services focus on the analysis of samples from Phase II/III clinical trials to afford the flexibility and capacity to accommodate even the most demanding sample analysis expectations and requirements. All sites are equipped with the most modern, high throughput instrumentation in the marketplace for the expeditious analysis of only a few samples or the analysis of tens of thousands of samples often associated with late-stage clinical trials. This includes analysis of samples from studies in patients with infectious diseases that are analysed in conjunction with our Biosafety laboratory Level 2 (BSL2) certification.     

Our GLP accreditation combined with over 40 years of bioanalytical experience exemplifies our long-standing commitment to meeting the needs associated with late-stage clinical development

As an added service we can also provide clinical supplies as well as logistics support for the collection and shipment of samples to our laboratories so as to offer a turn-key approach to sample analysis and the optimization of clinical study conduct.

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Discovery

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API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management