Our Quality Control Laboratory is equipped for the analytical control required for the development and manufacture of cell-based therapies, including flow cytometry and molecular biology tools.

Our team has a strong expertise in the development and validation of analytical methods for the major quality attributes, which enable us to deliver customized and GMP compliant assays for our clients’ products.

Our in-house safety testing methodologies include sterility, endotoxins and mycoplasma, with rapid methodologies for a quick turnaround analysis. All assays can be validated and qualified according to the relevant EP and USP methodologies.

We also provide comprehensive regulatory support for the preparation of IMP Dossier and other Quality documentation for clinical trials and hospital exemptions.




Process gap analysis
Process design and optimization
Critical Quality Attributes definition
Stability testing
Comparability studies

cGMP Manufacturing

Technology Transfer
Process Validation
Clinical Batch Production
Batch Release