Functional, Binding, and Cell-based Potency Assays Tailored to Your Therapeutic
Integrated CMC bioassay services through commercial release
Bioassays are central to product characterization and play a critical role in control strategies that ensure batch-to-batch consistency. With BioAgilytix, you gain direct access to the scientists managing your project, providing regulatory confidence, product reliability, and patient safety. Our single integrated team supports you seamlessly from development through commercial release, helping reduce timelines and accelerate success.
Purpose-built potency assays to support your CMC analytical strategy
We develop and validate potency assays aligned with your product’s mechanism of action (MOA). With deep expertise in functional and binding formats, we support cell-based and plate-based assays across multiple platforms such as:
- Enzyme activity and functional assays (e.g., cytotoxicity, apoptosis)
- Target-binding assays (e.g., ligand binding, target engagement, SPR)
- Gene and protein expression assays
- Vector copy number analysis
Integrated bioassay development and validation
Our consultative, science-forward approach ensures your bioassay is scientifically sound, scalable, and phase-appropriate. Whether you require rapid proof-of-concept data or comprehensive ICH-compliant validation, our team brings deep regulatory understanding and assay expertise to every engagement.
- Assay feasibility and optimization
- Method development and qualification
- Validation to ICH guidelines (Q2 (R2), Q14)
- Tech transfer, comparability, and bridging studies
Applications across modalities and regulatory stages
We support a wide variety of biologics and ATMPs at all phases—from IND through BLA and beyond, such as:
- Monoclonal antibodies (mAbs)
- Bi/Tri-specific antibodies
- Antibody-drug conjugates (ADCs)
- Proteins and peptides
- Fusion proteins
- Vaccines
- Gene therapies
- Cell therapies
Diverse platform capabilities for bioassays
Our labs are GMP-compliant and equipped with validated instrumentation to deliver precision and reproducibility at scale.
- Readouts: ELISA, MSD, qPCR, ddPCR, LC/HRMS, flow cytometry, imaging
- Systems: SpectraMax®, BioTek, QX200™, QuantStudio™, Orbitrap Exploris™, CytoFLEX, and more
- Facilities: GMP-compliant labs in Durham, North Carolina, US (FDA/EMA-inspected) and Hamburg, Germany (EU GMP-certified)
Comprehensive structural analysis and characterization
Ensure the safety, efficacy, and regulatory success of your biologics and advanced therapies with our CMC biophysical services.