See these pages for more details about specific services:
Assay Development / Establishment / Transfer
Using our experience and scientific knowledge, we can develop assays from scratch (assay development), transfer a validated method from a client (assay transfer/cross-validation) or transfer and optimise a non-validated assay from a client (assay establishment).
Assay Validation
Validation of analytical methods is crucial in generating data to be used in support of regulatory submissions. Following the most up-to date industry guidelines, BioAnaLab offers a comprehensive assay validation or cross-validation service. We validate as appropriate for the nature of the assay as well as the stage in drug development.
Validation criteria typically include accuracy, precision, sensitivity (limits of quantitation), specificity, assay range, robustness / ruggedness, system suitability and short-term stability.
Other critical aspects of the assay may need to be investigated such as cell passage number, drift, prozone (hook effects), matrix interference, parallelism and edge effects
Sample Analysis
We have the experience and capacity to perform sample analysis (PK / TK, PD, ADA) for large or small scale pre-clinical (GLP) or clinical studies (GCP). We routinely analyse drug substance or drug product for characterisation, batch release and stability studies (GMP).
Assistance with Clinical Trial Design
Design of clinical trials for therapeutic proteins demands an in-depth knowledge of their structure/function relationships. From the expertise gained through many years of developing biological therapeutics, we can help with advice on trial design, dosing schedules and sample collection time points and can also provide sample collection kits.
