LABORATORY SERVICES
Laboratory Services
One of the largest bioanalytical laboratories in Europe.
[email protected] www.nuvisan.com
NUVISAN
®
Pharma Services
LABORATORY SERVICES
Bioanalytics LC-MS/MS One of the largest bioanalytical laboratories in Europe.
CERTIFIED & UNDER SUPERVISION OF THE RESPECTIVE AUTHORITIES
NUVISAN PHARMA SERVICES
is a world leader in bioanalytical testing having one of the largest inventories of validated bioanalytical assays in the industry.
With more than 60 qualified scientists at the centre in Neu-Ulm, Germany,
NUVISAN maintains its leadership position as one of the premier bioanalytical laboratories in Europe to support the pharmaceutical industry for the analysis of drugs, metabolites, and endogenous compounds in biological matrices at all stages of product development.
EXPERIENCE
• Over 30 years of experience in Bioanalytics
• Well trained and highly motivated staff with an average of > 15 years of practical experience
• GLP certified since 1994
• Frequent inspections and excellent regulatory standing with a variety of regulatory
agencies to include EU, U.S.A. (FDA) and Brazil (Anvisa).
• > 300.000 samples per year analytical capacity
• > 500 non proprietary methods developed and validated in a wide variety of matrices and species
NUVISAN
®
Pharma Services
With our Bioanalytical capabilities we support the analysis of large and small molecules QUALITY
HIGHLIGHTS
sight in support of the study. In addition, our on-site Quality assurance department
• Biomarkers
All bioanalytical projects are 100% QC reviewed to provide an initial level of over-
audits each project with respect to adherence to SOP´s and applicable regulatory requirements (GCP, GLP) to ensure the delivery of data of the highest quality standard.
SERVICE OVERVIEW
• Bioanalytical method development and validation following the most recent international guidelines
• Peptides
• Steroid Hormones • Organic Nitrates • Prostaglandins
• Bisphosphonates • (Trace) Elements
• Bioanalytical method adaption and crossvalidation of
TECHNIQUES
• Bioanalytical services for toxicology studies under full GLP compliance
• GC/MS (EI , PICI, NICI)
existing methods
• Bioanalytical support for all types of Phase I studies (PK, PD, Interaction etc.)
• LC -MS/MS / UPLC -MS/MS • (LC -) ICP/MS
• Bioanalytical services to support large Phase II -IV multicenter studies
• Chiral Separations (LC and GC)
• Sample logistic services
• Dried Blood Spots
(>50 000 samples; >3 years duration)
• Biomarkers
• Highly flexible transfer of bioanalytical data in different formats
• Customized reports (including fully electronic) to meet individual sponsor needs
• Column Switching Techniques • Protein Binding
• Chemical Derivatization
• Multi Component Analysis
[email protected] www.nuvisan.com
LABORATORY SERVICES
Biopharmaceuticals At the highest levels of quality.
IMMUNOASSAYS AND CELL-BASED ASSAYS FOR THE DEVELOPMENT OF BIOPHARMACEUTICAL COMPOUNDS PK/PD Assessment for Biologicals
• In-house-development or transfer of sponsor methods to our labs
• Biomarker analysis including multiplex and ultra-high sensitivity analysis as well as cellular biomarkers
Immunogenicity Testing according to EMA Guidelines • Assay development and validation • Screening assays
• Confirmatory assays
• Assays for neutralizing antibodies
Cytokine Release Assays for Safety Assessment of Biologicals
• Combination of cell culture, stimulation, and cytokine detection • Stimulation of whole blood or defined cellular subpopulations • Protocols consider post TGN 1412 requirements
Functional testing of immune cells for mode-of-action analyses
• Separation and functional testing of immune cell populations from patient and/or volunteer samples (performed under a standing ethics vote for healthy volunteer sample analysis)
Immune-Monitoring of Clinical Trials
• World-wide collection, as well as quality-controlled processing, transportation
and analysis of samples for the monitoring of immune system parameters in single and multi-center clinical trials
Establishment and validation of commercially available kits
Method development and validation of novel bioassays
Method adaptation and validation of client methods
NUVISAN
®
Pharma Services
Available Instruments & Techniques
ELISA Reader
• Tecan Sunrise • Tecan M200 Pro
Multiplex System
• Meso Scale Discovery • Sector Imager 2400A
Ultra High Senivity Reader • Singulex Erenna®
Flow Cytometers • BD FACS Canto II • BD FACS Calibur
Access 2
• Beckman Coulter
Molecular Biology Equipment • PCR • Gel Electrophoresis • Gene cloning
CELL-BASED FUNCTIONAL ASSAYS
Defined healthy blood donors under EC vote Immune Cell Preparations • Whole blood
• Peripheral Blood Mononuclear Cells (PBMC) • Purified subpopulations • Animal tissues
Antigen specific stimulations Polyclonal stimulations
Functional read-out after stimulation
• Cytokine Release (ELISA, ELISPOT, ICS, ECL readout)
• Cell proliferation (ATP-based metabolic, BrdU, CFSE)
• Expression of (activation) markers • Apoptosis induction • Oxidative Burst • Chemotaxis
• NK-cell activity
• Cytotoxicity testing, toxicity screening
• Signal transduction (CA2+-flux, phosphorylation) • NO-production
• Histamine release
Analysis of samples (i) generated in house in the Nuvisan clinic or from in vitro / ex vivo projects (ii) from Nuvisan clinical trials performed at external clinical sites and (iii) from external clinical trials
CYTOKINES & BIOMARKERS
V-PLEX pro-inflammatory IFN-gamma IL-1beta IL-2 IL-4 IL-6
IL-8 IL-10 IL-12p70 IL-13 TNF-alpha
Eotaxin Eotaxin-3 IL-8 (HA) IP-10 MCP-1
MCP-4 MDC MIP-1alpha MIP-1beta TARC
GM-CSF IL-1alpha IL-5 IL-7 IL-12/23p40
IL-16 IL-17 TNF-beta VEGF IL-15
octreotide IGF-2 BD-2 IL-23 LTB4 M30
M65 TGF-beta pAKT total AKT pPRAS total PRAS
GLP-1 GLP-2 P1NP CTX Glucagon Insulin
Aldosteron STAT3 STAT5 GM-CSF IL-23
V-PLEX chemokines
V-PLEX cytokines
ADDITIONAL MARKER
EXPLORATORY
• Innate immunity evaluation via stimulation of Toll-like receptors (“TLR stimulation assays”)
[email protected] www.nuvisan.com
LABORATORY SERVICES
Pharmaceutical Analytics We bring your product in a simplified, accelerated path from benchtop to clinic and beyond.
CERTIFIED & UNDER SUPERVISION OF THE RESPECTIVE AUTHORITIES
PHARMACEUTICAL ANALYTICS
Our Pharmaceutical Analytics highly automated laboratories are well equipped with the most modern UPLC / RRLC , HPLC, GC, and Dissolution Systems as well as employ some of the brightest scientists in the industry.
NUVISAN Pharma Services offers a unique “One Stop Shop” concept, providing
analytical testing as well as formulation development, clinical trial material manufacturing, clinical packaging, distribution, clinical services, and bioanalytics, all under one umbrella.
These integrated services will bring your product in a simplified, accelerated path from benchtop to clinic and beyond.
EXPERIENCE
• Well trained and highly motivated staff with over 60 people and an average of over 10 years of practical experience
• Frequent inspections and excellent regulatory standing with a variety of regulatory agencies
• Small Molecules
• Biopharmaceuticals
• Active Pharmaceutical Ingredientes and Intermediates • Narcotics
• Implants & women healthcare • GMP certified
NUVISAN
®
Pharma Services
With our high quality services we demonstrate your product’s safety and efficacy. SERVICE OVERVIEW
FACILITIES FOR STABILITY TESTING
• Method validation
• Validated conditions according to
• Method development · Protocol preparation according to ICH /VICH
· Analytics, Validation report
• Stability studies
· ICH and VICH stability studies · In-use stability &
Interaction studies
· Photostability studies (Option 1 and 2)
· Freeze-thaw studies · Cycling studies
(temperature – humidity)
• Compatibility studies
• Cleaning method development / validation
• Forced degradation studies
• Pharmaceutical batch control
Stability Storage Facilities
ICH /VICH : t ± 2°C; ± 5 % rel. hum.
• Continuous electronic monitoring
NUVISAN Pharma Services has a broad experience in the following methods •
Stability Storage Conditions
•
• 25°C / 60 % rel. hum.
•
• 5°C
• 30°C / 65 % rel. hum. • 40°C / 75 % rel. hum.
•
•
• 30°C / 75 % rel. hum.
•
• -20°C Walk-in-Freezer
•
• 30°C / 70 % rel. hum.
• Back-up Chamber
• Various special conditions (-80°C etc.) • Reference Samples contr. RT
• Versatile stability chambers for
special conditions, e.g. 25°C/ 40% RH or 40°C/25% RH for semipermeable containers
• Support in process testing
• Cyclic Temperature /
• Tox formulation analysis
• Freeze-Thaw-Cycling (-30 to 80°C)
• Container closure integrity testing
ANALYTICAL METHODS
•
HPLC (UV-, MWD-, RI -, ELSD-, CAD-, Fluorescence-, Electrochemical-Detectors) UPLC /RRLC SEC
Dissolution Testing Apparatus 1, 2, 3, 4, 5 & 6 UV-VIS Spectrophotometry GC (FID, Headspace) TLC /HPTLC
Automated Titration
•
Karl-Fischer
•
Pharmaceutical-Technical Parameters
•
• •
Physico-Chemical Parameters /Mechanical Parameters
Capillary Electrophoresis (CE) Peptide Mapping
Humidity Programming
with defined cooling and heating rates
[email protected] www.nuvisan.com
NUVISAN
®
Pharma Services
Our resources become yours.
Fully integrated Contract Research Organisation with over 35 years of serving the pharmaceutical industry. A leading CRO driven by Experience, Commitment, and Technology made in Germany. NUVISAN GmbH Wegenerstrasse 13 89231 Neu-Ulm[nbsp] Germany
Phone: +49 731 9840 0 Fax: +49 731 9840 280 NUVISAN Analytical Services GmbH Im Wirrigen 25 45731 Waltrop Germany
Phone: +49 2309 9376 0 Fax: +49 2309 9376 420
Nuvisan Pharma Grafing GmbH Am Feld 32 85567 Grafing Germany
Phone: +49 8092 7008 0 Fax: +49 80832 7008 99
