Integrated Bioanalytical Solutions for Complex Scientific Challenges
Our 260 square meters bioanalytical laboratory offers a suite of comprehensive mass spectrometers and bioassay platforms to support your preclinical and clinical programs. Our services span from regulated mass spectrometry to immunogenicity and biomarker ligand-binding assays to provide reliable data for decision making.
We can support you whether you require assay development, validation or sample analysis. Methods can be transferred from the Sponsor or produced from scratch. The latter allows our team to use its consolidated technical knowledge and connect with the broad expertise of Frontage Laboratories Inc. to deliver customized assays.
Frontage Europe laboratory is GLP (Good Laboratory Practice) certified and meets the requirements for GCP (Good Clinical Practice). Method validation, sample analysis and reporting comply with the harmonized standards of the ICH M10 guideline, adopted by EMA, FDA and major regulatory bodies.
Our platforms include:
- Triple-quadrupole & hybrid mass specs
- UPLC pumps
- ELISA Assays (Colorimetric, Fluorescence, Chemiluminescence)
- MesoScaleDiscovery (Electro-chemiluminescence)
- Quanterix Simoa
Our instruments include:
- SCIEX 6500 QTRAP
- SCIEX 5500
- Exion ULPC systems
- Spectramax ID3
- Glomax Navigator
- MSD QuickPlex SQ120MM
- Quanterix Simoa HD-X Analyzer
- Tecan Spark20M
- Fujirebio Lumipulse G1200
All softwares for data acquisition and processing go through rigorous internal validation.
The validated laboratory LIMS (Watson 7.6, CFR21 part 11 compliant) is used for efficient sample tracking, to store bioanalytical data and generate method performance statistics.
Bioanalysis is not a stand-alone process. Our internal QA program assures the adherence to a framework of robust SOPs and performs regular study-phase and process inspections.
Bioanalytical Samples
The laboratory is located only 25 km away from Malpensa airport, making samples logistics easy. We have a dedicated team for sample tracking and rely on a customs broker for extra EU samples import.
In-house storage capabilities include both -80°C and -20°C freezers. Samples storage temperature is monitored continuously by a validated system (Elemental Machines).
Samples management includes:
- Emergency Alerts to on-call staff
- Audit trail tracking of samples (21 CFR, part 11 compliant)
- Digital storage history of each sample
- 24-h temperature monitoring
We value our clients’ data
Protecting data is not only a matter of operational integrity but a regulatory compliance. Our computerized systems are validated and maintained in compliance with FDA 21 CFR part 11, OECD and EMA guidelines. Automatic daily incremental backup is performed for data on server and instrument workstation; full back-up is regularly performed. Business continuity and disaster recovery are tested each year.
