Analytical services
Custom assays & full-process QC for advanced therapies.
More than 30 analytical scientists, two decades of ATMP testing experience, state-of-the-art instrumentation — enabling product & process understanding through advanced analytics.
Key advantages
Regulatory-aware, timely, sample-efficient
Regulatory navigation
Deep understanding of ATMP regulatory challenges to guide clients through complex analytical requirements.
Timely product delivery
Rapid testing methods and streamlined processes accelerate release and meet critical timelines.
Optimised sampling
Prioritise product quality while minimising sample volume impact — especially for small-scale programs.
Capabilities
Testing platforms & compliance
21 CFR Part 11 & Annex 11
Full data integrity compliance.
cGMP method validation
Validation and transfer under GMP.
Diverse vector types
Expertise across AAV, LVV, mRNA, exosomes and more.
Reference standards
Generation and characterization from development or at-scale runs.
On-site stability chambers
In-house stability under various conditions.
Comparability studies
Extended characterization & analytical comparability.
Custom development
Novel assays for client-specific requirements
For advanced cell and gene therapy products, specialised QC assays are often required to measure unique product features not captured by standard tests. Our team supports:
- Compendial & custom assays
- Novel assay design and development
- Method transfer to & from client QC labs
- Transfer of in-house developed methods to clients
- Extended characterization
- Comparability studies