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Assay development
Custom methods designed for specific regulatory endpoints to ensure your clinical biomarker data withstands agency scrutiny.
Scientific rigor for specialized endpoints
We design custom bioassays strictly around the anticipated clinical biomarker readouts of your rare disease program. Our senior team identifies operational challenges early and establishes the exact context of use to ensure every method is fit for purpose before laboratory work begins.
Defensible data for accelerated pathways
We generate regulatory-compliant outputs that satisfy stringent FDA and EMA expectations for primary and secondary biomarker outcomes.
Context of use alignment
We align your bioassay strategy with the specific requirements of your trial to ensure your target biomarkers are measured accurately and prevent costly downstream rework.
Gene therapy endpoints
We develop advanced methods utilizing digital droplet PCR and quantitative PCR to measure transgene expression and vector purity accurately.
Flexible integration
We rapidly apply your existing protocols or generate tailored instructions for other vendors to ensure smooth sample exchange.
Discuss your assay requirements
Engage our senior scientists to define the context of use and develop custom bioassays for your specific biomarker targets.
Specialized development for rare disease research
Our scientific team applies decades of specialized research to the disciplined execution of your program. We leverage deep historical insights across established rare disease models to identify vulnerabilities and accurately track disease biomarkers.
Unmatched sensitivity:
Our established Western blot methods detect dystrophin biomarker levels as low as 0.25%, enabling capture of subtle therapeutic signals.
Specialized analysis:
We develop immunofluorescence bioassays that accurately map dystrophin localization and intensity across tissue samples.
Treatment-emergent antibodies:
We utilize the Luciferase Immunoprecipitation System (LIPS) to detect specific antibodies in serum and plasma samples.
Regulatory readiness:
We design validation plans to satisfy rigorous FDA expectations for primary trial outcomes.
Predictable schedules for custom validation
Developing and validating custom bioassays typically takes two to four months, depending on the specific method requirements.
Integration with central laboratories
AGADA Biosciences acts as a collaborative partner built to integrate directly into your existing vendor ecosystem. We generate specific protocols for other vendors and advise on best practices for sample transport and storage.
Strategic guidance beyond basic execution
Our lean model keeps scientific expertise close to the work, ensuring fast escalation paths and direct access to senior leadership.
Validation oversight:
Our team provides specific input on your methods before laboratory work begins to ensure strict regulatory alignment.
Clear accountability:
We manage specialized workflows without requiring full control of your trial.
Harmonized workflows:
We align efficacy studies and clinical SOPs to streamline transitions and reduce technology transfer time.
Submission readiness:
You receive defensible data packages designed to withstand rigorous agency scrutiny.
Start a conversation
Reach out to our team to develop fit-for-purpose bioassays that accurately measure your program’s biomarkers.
Where history meets innovation
In the heart of downtown Halifax, AGADA has transformed a historic building into a modern facility dedicated to advancing rare disease therapeutics. Take a closer look at our laboratories, scientific capabilities and dedicated team and discover how our unique location and collaborative environment support the work we do for clients and patients worldwide.
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.
Meet our scientific leadership
Our founders and senior scientists are globally recognized leaders in rare and neuromuscular disease research, bringing decades of specialized expertise to your program.
News and resources
We design custom bioassays strictly around your anticipated clinical biomarker readouts to ensure your methods remain fit for purpose and withstand agency scrutiny.
