Services
Bioanalysis
Indicia Biotechnology as a Contract Research Organization, is the true partner of pharmaceutical/biotechnology companies who are looking for bioanalytical testing capabilities, expertise, rigour and flexibility.
The bioanalytical services of Indicia include method development, assay validation, and specimen analysis using different technical platforms such as:
Indicia Biotechnology works with qualified commercial reagents or tailor-made tests developed exclusively for the sponsor.
Sample bioanalysis are performed in a GLP-like environment.
Method validation and equipment
Indicia Biotechnology follows different guidelines for its R&D and Testing activities depending of the application fields:
- FDA: Bioanalytical method validation (May 2001) - specially for immunoanalyse
- EMEA: guideline on validation of bioanalytical methods – Committee for medicinal products for human use – November 2009
- ICH topic Q2(R1) – Validation of analytical Procedures
Indicia Biotechnology can also carry out the validation method under the own procedure of the sponsor if requested.
The “level” of validation is fixed with the sponsor according to its requirements and the objective of the study: internal research program, proof of concept, pre-clinical or clinical studies.
Our ISO 9001 procedure or our SOP describes our way to conduct samples testing services like:
- how samples are segregated and chain of custody procedures
- how are Reference Standards characterized, calibrated, and qualified
- where records are stored/archived and for how long
- process followed for review and reporting test data
Equipment
All our laboratory equipments are verified by specialist providers ISO 9001:2000 certified and COFRAC accredited.
Temperature of freezer (-20C / -80°C) and cold rooms are monitor by an alarm system.
Ultra-sensitive bioanalysis
INDICIA Biotechnology is the only European CRO to provide services relating to ERENNA® technology, thanks to its partnership with California company SINGULEX, Inc.
This new platform makes it possible to measure biological molecules on the femtogram scale, meaning at a level of sensitivity ten to hundred times higher than using conventional technology.
The company builds tailor-made bioanalytical testing services or new test development.
Its catalogue features a menu including fifty parameters involved in five different therapeutic fields (inflammation, oncology, cardiovascular, metabolism, neurology and toxicity).