In addition to established analytical methods, DINAMIQS has experience in developing product-specific, cell-based assays to support the characterization of biological activity and product performance. Genome integrity can be extensively characterized by next-generation sequencing using an in-house bioinformatics pipeline, enabling detailed assessment of vector genome identity, integrity, and sequence variants.

Product-specific analytical methods will be developed, implemented and optimized in DINAMIQS laboratories to support process establishment and to prepare for subsequent GMP qualification activities.

Analytical standard methods developed and performed in-house are described in the following table (not exhaustive). Additional assay development and method transfer can be performed or outsourced according to project specific needs.

For early phase clinical material, analytical methods undergo qualification. This ensures that methods are reliable, reproducible, and fit-for-purpose at an early clinical stage. Qualification typically covers accuracy, precision, specificity, linearity, range, and detection limits to the extent relevant. We use ICH Q2(R2), USP <1033>/<1047> as frameworks.

For late phase/commercial programs, methods progress to full validation. System suitability criteria, reference standards, and trending controls will be implemented as integral part to each method.