BIOANALYSIS, IN-VITRO ADME AND METABOLISM
Unilabs Serving Pharma is Europe’s leading independent Bioanalytical Contract Research Organizations (CRO) and offers complete bioanalytical support for your entire drug development process from discovery with clinical trials through to post-marketing surveillance (Phase IV).
Our bioanalytical services are supported by Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) ensuring high-quality results and data meeting your regulatory requirements.
Unilabs Serving Pharma provides a full method development or transfer service including method validation, with study plans designed to satisfy the latest regulatory guidelines. Our focus is on providing you quality data and in a timely manner.
Why choose Unilabs Serving Pharma?
We have the instrumentation and capacity to comfortably accommodate your large-scale sample analysis studies.
We routinely support fast turnaround (e.g. first into a man) studies.
We operate a one-study per instrument scheduling policy for Liquid Chromatography/Mass Spectrometry (LC-MS/MS) systems, to optimize instrument performance and method reliability.
We support both preclinical and clinical development and dedicate time to carrying out smaller studies, and we recognize the importance of all of our clients.
Our services
- Experienced, proactive, and responsive scientists
- A dedicated SD who is in control of all stages of the process
- All scientists within their teams qualified to at least degree level
- Flexible scheduling to meet your timelines
- High ratio of QA to operational staff, enabling fast reporting of audited data
- High-quality bioanalytical data and scientific guidance
Immunoassay
- PK/PD Assays
- Immunogenicity Assessment
- Biomarkers
Mass Spectrometry
- PK/PD Assays
- Small molecule, Protein and Peptide Analysis
- Biomarkers
Our range of state-of-the-art instrumentation includes:
- MDS SciexTM API 4000 and 5000 LC-MS/MS
- Waters XevoTM TQ-S LC-MS/MS
- Waters Acquity UPLC®
- Shimadzu Nexera UHPLC
- Spark-Holland SymbiosisTM Pharma
- Cohesive TurboFlowTM HTLC systems
- Hamilton MicroLab Star Liquid Handling Workstation
We provide data and knowledge to clarify key biotransformation issues
Whilst we have a list of validated methods, we recognize that you might require your methods tailored to specific concentrations in specific matrices for specific indications.
Examples of our experience
Bioanalytical experience
- More than 20 years and 3,500 bioanalytical studies conducted on small and large molecules
- Developing, validating, and implementing sub pg/mL assays
- Experience with immunogenicity towards viral vectors
- Experience with LPL deficiency testing, coagulation factors, FIX activity, FIX protein, FIX Inhibitors
- Experience with multiple sample types including blood, urine, feces, tissue, and CSF
In-Vitro ADME and Metabolism
- Bioanalytical and ADME support for complex analytes and atypical drug modalities including In Vitro ADME screening
- Full metabolite characterization service from early discovery in vitro experiments to late development radiolabelled studies
- Discovery Bioanalysis - Rapid fit-for-purpose service for in vitro and in vivo discovery studies