Assay Development and Validation Services
Bioanalysis to support drug development is rarely one-size-fits all. Differences in drug modalities, therapeutic indications, and clinical or preclinical study design impact the strategies required for designing appropriate support. Assay creation is a critical component of this process and partnering with experienced bioanalytical partners is a critical component of a successful therapeutic program.
Partner with experienced bioanalytical scientists for assay support
BioAgilytix provides de novo assay development, method transfers, partial validations, cross-matrix validations, GxP-compliant validations, or any combination of these required to meet your bioanalytical needs in a fit-for-purpose manner. Each analytical support strategy should be tailored to match the therapeutic modality, the scientific and mechanistic considerations, and the required regulatory rigor for your preclinical or clinical stage of testing.
BioAgilytix has over 600 scientific staff globally to support your program, all with a singular focus on bioanalysis and compliance. Our experienced scientists will work with you to ensure that we provide the most appropriate assay for your bioanalytical needs.
Custom assay development for every drug program
At BioAgilytix, we design appropriate assay strategies driven by the stage of drug testing so our bioanalytical solutions are fit for purpose and tailored to the context of use for the end data. We work diligently to ensure our sponsors receive exactly what they need and are not over- or undersold on capabilities or platforms. Our team delivers high-quality assays appropriate to the regulatory expectations for each program.
BioAgilytix has experience with thousands of sponsors. In fact, we have over 100 years of combined organizational experience in bioanalysis and assay development across our global sites. When partnering with our clients, we leveraged this experience to develop assays consistent with industry standards and regulatory expectations.
Our assay creation capabilities and techniques
BioAgilytix has a wide array of platforms available for use in bioanalytical testing. We have a rigorous equipment management program and continually invest in maintaining state-of-the-art, high-capacity laboratory spaces at each of our sites. Our quality systems infrastructure is appropriate for regulated work including GxP and CLIA. BioAgilytix has expertise in designing and validating assays in support of PK, immunogenicity, biomarkers, and CMC bioanalytical, making it possible for our sponsors to collaborate with one vendor for all of their bioanalytical needs, including:
- Ligand-binding assays/immunoassays
- Cell-based assays
- Molecular biology/quantitative PCR (qPCR)
- LCMS – small and large molecule
- Virology toolsÂ
- Protein binding assays
BioAgilytix’s approach to assay creation solutions
When global studies create new logistics challenges, BioAgilytix is positioned to support different assay development strategies. Our multiple locations allow us to serve North America, Europe, and APAC with experience maintaining compliant assays across various global regulatory agencies. These locations also provide flexibility to our clients with the ability to internally move or transfer assays from one site to another to meet new geographical needs.
At BioAgilytix, we have a unique model for assay development, qualification, validation, and testing. Here, one team executes all stages of the assay lifecycle so the same team that builds your assay is the same team that uses the assay during sample analysis. This approach ensures that we have exceptional continuity of service and can build better long-term partnerships. Our focus is always to deliver high-quality assays and data in a timely manner to support your programmatic needs.