Assay development solutions tailored to your needs
The successful implementation of a biomarker endpoint is highly dependent on the availability of assays and on reliable measurements of markers in biological samples. While a large number of assays are on the market, scientists often have an urgent need for assays meeting specific requirements.
To enable innovative biomarker development for drug discovery and diagnostic application, Firalis provides Custom Assay Development Services to customers, including diagnostic, biotechnology, and pharmaceutical companies as well as academic institutions. Using a large portfolio of assay technologies, Firalis can design and develop sensitive, reproducible and highly validated immunoassays for investigational or translational research:
- Development of critical reagents, including antibodies, peptides and recombinant proteins
- Customized quality control and full analytical validation
- Development and optimization of assays with predefined performance criteria
- Immunoassay Development (ELISA, MesoScale Discovery, Luminex, Singulex, Ella…)
- Complete ELISA kit manufacturing (GMP compliant)
- ISO 13485 certified assay development and ISO 17025* accredited validation of immunoassays
- IVD development from concept to approval
Firalis’s scientists have extensive experience in synthesizing critical reagents in solution or lyophilized and to ensure best performance. Generated antibodies are controlled for biomarker detection at each critical step. The development of specific immunoassays can be part of an antibody development project or can be initiated using existing assay-specific reagents supplied by the client. The project schedule will be defined together with the customer and at predefined milestones Firalis will provide information on vectors, cell lines, antibody, recombinant proteins, assay kits and other reagents or data. Full confidentiality in all contracts is assured.
Depending on desired applications, Firalis can develop various types of assays (sandwich ELISA, direct ELISA, Western Blot) but also can transfer the technology on other platforms such as Luminex, MesoScale Discovery, Singulex, Ella, which are suitable for screening and evaluating targets of interest.
We are also able to perform other studies such as drug exposure efficacy, response to treatments and pathways signatures.
Firalis strengths in Assay Development Services are based on:
- Comprehensiveness: Services span from immunogen generation to assay production and CE marking.
- Flexibility: Development of assay on the platform of your choice
- Efficiency: At project kick-off, Firalis guarantees a turnaround time for each step of the process. In case of questions, Firalis guarantees to reply within 24 hours
- Superior client service: Direct interactions with a dedicated project team at each project step, providing insights and proposing strategies
- Highly competitive pricing
Develop and validate IVD/CE marked-kits with FIRALIS
Firalis also provides contract manufacturing services to the diagnostic and research industry and can quickly deliver custom assays for any biomarkers and bring new IVD products to market from concept to approval.
*Accreditation No 8-3139. Scope available on www.cofrac.fr
Please contact us to get more information about our Custom Assay Development Services and discuss with our experts to evaluate feasibility of your project.