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Bioanalytical method validation
Bioanalytical services, pre-validated methods and fit-for-purpose bioassays designed to accurately measure critical biomarkers and accelerate rare disease drug development.
Alleviating heavy validation burdens
Regulatory expectations for primary and secondary biomarker outcomes require rigorous method validation. As a specialist biomarker CRO, AGADA Biosciences provides pre-validated, FDA-reviewed bioassays for rare disease programs to help you avoid months of setup time and hundreds of thousands of dollars in internal costs. Our senior scientists ensure every method is strictly fit for purpose based on the specific context of use for your trial.
Expanding capabilities for gene therapy
Our team supports efficacy studies with advanced bioanalytic methods to quantify transgene expression. We leverage tools like digital droplet PCR and quantitative PCR to accurately measure your vector purity and critical gene therapy endpoints.
Assay development
We design custom bioassays strictly around the anticipated clinical biomarker readouts of your program. Our senior team identifies operational challenges early so you receive defensible data packages that withstand stringent agency scrutiny.
Validated bioassays (off-the-shelf)
Our off-the-shelf methods for Duchenne and Becker muscular dystrophies are ready for immediate deployment to measure key biomarkers. Our shared-cost model saves sponsors up to $600,000 and cuts two to four months from standard validation schedules.
Existing bioassays
We rapidly apply your existing protocols or generate tailored instructions to suit your specific biomarker program needs. Our integration-first approach allows us to coordinate smoothly with your other vendors to process serum and tissue samples.
Translational strategy consulting
Successful rare disease programs begin with the right strategy. AGADA’s senior scientific team provides expert translational and regulatory guidance to help you define study objectives, select meaningful biomarker endpoints, and generate evidence that supports confident decision-making. By aligning your program with FDA and EMA expectations from the outset, we help reduce risk and accelerate development.
Accelerating deployment with established science
We apply decades of rare disease research to the disciplined execution of your program. Our lean model gives you direct access to the senior scientists overseeing your study, so decisions are made in minutes rather than weeks.
Shared-cost model:
Our off-the-shelf bioassays save sponsors between $400,000 and $600,000 in internal validation costs.
Accelerated timelines:
Utilizing our pre-validated methods cuts two to four months from standard setup and validation schedules.
Unmatched sensitivity:
Our established Western blot methods detect dystrophin biomarker levels as low as 0.25%, enabling capture of subtle therapeutic signals.
Specialized endpoints:
We provide specific immunofluorescence and Luciferase Immunoprecipitation System (LIPS) assays to detect treatment-emergent antibodies and accurately map disease mechanisms.
Start a conversation
Discuss your bioassay strategy with our experts to deploy pre-validated bioassays or develop custom methods to measure your critical biomarkers.
Advancing rare disease research
Explore how AGADA supports rare disease programs across the drug development journey. From preclinical mouse efficacy studies to the collection, preservation and analysis of muscle biopsies from clinical trials, our scientific and quality teams work together to generate robust, reliable data designed to meet regulatory expectations.
Quality and compliance
We operate in strict compliance with GCP, GLP and GDPR regulations to ensure your data remains interpretable and defensible. Every team member must hold a CITI certification before supporting any sponsor trial.
News and resources
AGADA Biosciences provides pre-validated bioassays and fit-for-purpose method development to accurately measure rare disease biomarkers and ensure regulatory readiness.
