Custom Potency Assays
A phase appropriate custom potency assay is a critical component of getting a new drug to market. Whether using basic or full qualifications (in line with ICH Q2B Validation of Analytical Procedures) for assessment from discovery through to GMP stability and lot release testing, these product-specific potency assays support key requirements of stability studies and lot release applications.
Regulatory-Ready Bioanalytical Services
BioOutsource offers a comprehensive investigational new drug (IND) service featuring standard or custom potency assay development. We have scientific experts that are dedicated to working with you to design an assay from scratch, optimize an in-house assay at any stage, or tech transfer a fully qualified or validated assay for routine testing and monitoring.
Designed and carried out in accordance with the regulatory requirements of USP1033, European Pharmacopoeia and ICH Q2B, our scalable bioassays support IND development from early discovery and research through to clinical manufacturing and commercialization. We are also able to align comparability studies and evaluate new process changes, including:
- Custom Assay Development (varied end points) to measure Neutralization
- Cell Proliferation/Cell Death (Apoptosis)
- Cytokine Release
- Modulation of Cell Signalling (phosphorylation events)
- Modulation of the Inflammatory Response (immune cell function/recruitment)
- Receptor Binding/Receptor Activation
- Ligand Binding
- Calcium Flux
Contact our expert scientists today to discuss how our range of analytical services can improve your unique process.