With a wide range of disciplines encompassed by its staff, Lab21 has the experience to undertake a wide range of specialised or routine projects. Lab21 has wide experience in providing GCLP accredited esoteric and routine diagnostic services for clinical trials including patient stratification, drug efficacy, genotyping and biomarker analysis.
Lab21 clients include leading companies in the CRO, Pharmaceutical and Biotechnology industries and we have successfully completed multiple projects and clinical trials using molecular diagnostic, pharmacogenetics, pharmacokinetics, drug resistance, immunoassay and routine marker analysis.
Our expert services use gold standard commercial assays or bespoke assays developed by Lab21 from initial biomarker identification or by transfer of Client’s technology.
Lab21 clinical trials services include full project management, data management (21CFR Part 11 compliant), sample logistics and sample storage services to our Clients on an individual basis. We can manage the clinical sites with training, world-class logistics, sample tracking and ability to rapidly, securely and efficiently move samples globally.
Please see below for examples of specialist and routine diagnostic assay technologies already in use at Lab21.
Molecular Diagnostics & Pharmacogenetics:- Real-time PCR (Traditional and Proprietary technology)
- Bead-based multiplex analysis
- Various sequence-based analysis methods
- DNA and RNA extraction from various tissue types
Pharmacology:- Pharmacokinetics
- Bio-equivalence studies
- Drug-drug interaction studies
- Dose escalating studies
- Clinical interpretation/bioinformatics
Viral Drug Resistance:- Genotyping
- Phenotyping
- Viral drug resistance selection, profiling and monitoring
Immunodiagnostics:- Gene synthesis, Protein Expression and Purification
- Antibody production (Polyclonal and Monoclonal)
- ELISA
- Cell Agglutination
- Immunoblot
- FACS technologies
- Point-of-care applications
- Proprietary SelahDot™ technology for in vivo imaging, in vitro diagnostics, lateral flow devices, FRET
Viral propagation:- Artificial HCV replication systems
- Primary antiviral screens
- Viral load quantification
- Broad spectrum antiviral screens
- Cat III facilities
Cellular assays:- Dose escalation
- Drug combination studies
- Cellular toxicity assessment
Bespoke custom assays can also be developed by Lab21 from initial biomarker identification, from published protocols or by transfer of Client’s technology. Custom projects are afforded senior scientific input and include full validation in Lab21’s hands.