Assay Development Services
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: Turn-key services from immunogen generation up to assay production or CE-marking
- Flexibility: Development of assay on the technology platform of your interest/choice
- Efficiency: At project kick-off meting, we guarantee a turnaround time for each step of the service contract
- Superior client service: For each step, a dedicated team provides you insights and reply your questions
- 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.
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