(Non)-Regulated Bioanalysis

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Non Clinical

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 longterm experience in de novo assay-development of ELISA and Meso Scale Discovery (MSD) assays. We can support you with off-the-shelf, costumer fit-for-purpose assays and flexible personalized (U-PLEX) and validated (V-PLEX) Mesoscale assays.

Mass Spectrometry (LC/MS)
Our European LC-MS/MS laboratories fully support both the development and validation of bioanalytical methods in a variety of species matrices as well as the GLP analysis of samples from non-clinical studies.

LC-MS/MS laboratories located at 3 sites in Europe and experienced in the analysis of samples from non-clinical studies afford the flexibility and capacity to meet your needs.  All sites are equipped with modern, high throughput instrumentation for the expeditious analysis of samples.  In addition, expertise with multiple processing techniques including protein precipitation, liquid-liquid extraction, solid phase extraction, derivatization, and column switching, foster the development of the optimum method to meet each project’s requirements.

We offer not only quantitative drug and metabolite analysis but also supporting services to include metabolite identification as well as in vivo and in vitro drug metabolism and pharmacokinetic services.

Our GLP accreditation combined with over 40 years of bioanalytical experience and our in-house non-clinical ADME/DMPK services exemplifies our long-standing commitment  to meeting the needs associated with non-clinical sample analysis.  

Clinical Phase 1

Mass Spectrometry (LC/MS)
Our European centred LC-MS/MS laboratories fully support both the development and validation of bioanalytical methods, as well as the analysis of samples from Phase I clinical trials to include not only the sponsor’s compound of interest but also a wide variety of supportive assays so as offer a comprehensive service to our customers.

Our LC-MS/MS services focus on the analysis of samples from Phase I clinical trials to afford the flexibility and capacity to accommodate even the most demanding sample analysis expectations and requirements. All sites are equipped with modern, high throughput instrumentation for the expeditious analysis of samples. This includes analysis and reporting by cohort, as often required in the course of SAD/MAD investigations, as well as the analysis of large bioequivalence type studies involving hundreds of subjects. In addition, we offer a large number of validated off the shelf non-proprietary assays to support DDI assessments, to include multicomponent cocktail type assays, as well as assays to support PD parameters and biomarkers.

Our GLP accreditation combined with over 40 years of bioanalytical experience exemplifies our long-standing commitment to meeting the needs associated with Phase I 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.

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 analyzed 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 a 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 support 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 at our own in-house clinic located at the same site as the Immunology laboratory assure that we work with the freshest material possible.

Mass Spectrometry (LC/MS)
Our European centred 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.

Download our PDF-brochure:

Bioanalytical solutions

For your drug development

>> download NUVISAN Bioanalytical Brochure | PDF | 1,5 MB

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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