Method Development, Validation and Transfer
Nordic BioAnalysis AB supports customers with the development, validation and transfer of analytical methods across microbiology, biochemistry and chemistry. We assist in refining existing methods to improve reliability, repeatability and regulatory suitability.
Our analysts evaluate current method design, test parameters, instrumentation and documentation in order to identify challenges and propose corrective actions. The service can be offered as stand-alone support or as part of a broader testing assignment.
Project approach
Each assignment begins with a review of the existing method documentation, prior results and test setup. Based on this, we propose targeted modifications or confirmatory tests. Work is carried out by qualified staff under GMP or ISO-aligned procedures as appropriate.
Method Development
We develop new analytical methods and optimize existing ones for improved performance, adaptability, and compliance.
- Techniques supported: HPLC, GC, UV-Vis, titration, osmolality, elemental analysis, and microbiological methods
- Custom development: Tailored to product type, sample matrix, and regulatory context
- Optimization: Improved sensitivity, repeatability, and robustness through method refinement
- Root cause analysis: Identification and resolution of variability or performance issues
Method Validation
Validation is conducted in accordance with ICH Q2(R1), Ph. Eur., or client-specific requirements, with full documentation and traceability.
- Specificity: Differentiation of analyte from excipients, degradants or matrix components
- Linearity & range: Verified response across the intended concentration span
- Accuracy & precision: Assessment of trueness and reproducibility
- LOD & LOQ: Established detection and quantitation thresholds
- Repeatability (Intra assay) & intermediate precision (Inter assay): Tested under varying conditions
Method Transfer
We support the transfer of validated analytical methods between laboratories, contract partners, or manufacturing sites through:
- Transfer Protocol Design: Structured protocols with clear test plans and acceptance criteria.
- Cross-Site Implementation: Coordination of testing across sites to confirm method equivalence.
- Post-Transfer Support: Technical assistance to resolve issues and maintain performance after transfer.
Applicable areas
We provide method development and validation services in the following areas:
- Microbiological and Molecular biological methods: Including incubation conditions, contamination issues and media suitability test.
- Biochemical and chemical methods: Including separation techniques, detector sensitivity and sample preparation.
When relevant, additional studies such as growth curve monitoring or re-validation can be performed to confirm improved method performance.