WHERE WE ADD VALUE
What we do
Technical expertise for the analytical and development decisions that shape advanced therapies.
Cellvanta flexibly supports early stage cell and gene therapy programmes with independent expertise across product understanding, analytical development, potency and CMC strategy.
The focus is on generating and interpreting the evidence needed to understand the product, manage technical uncertainty and make informed development decisions.
Product Understanding
Understanding an advanced-therapy product requires more than measuring individual attributes. Cellvanta helps teams establish what matters about the product, how those attributes relate to its biology and whether the analytical strategy provides sufficient evidence for development decisions.
Capabilities
Product characterisation
Critical Quality Attribute (CQA) strategy
Analytical strategy
Comparability
Analytical gap assessment
Technical risk assessments
Cell-based assays need to generate reliable evidence while working within the biological and practical constraints of an evolving development programme. Cellvanta provides specialist support across assay design, optimisation, troubleshooting and qualification to support data packages for IND/CTA.
Cell Therapy Assay Development
Capabilities
Flow cytometry panel design and development
Marker selection and optimisation
Cell-based assay development
Assay troubleshooting
Assay qualification
Analytical method review
Analytical transfer & readiness
Potency is often one of the most challenging analytical questions in cell therapy because biological understanding, product definition and manufacturing processes evolve together. Cellvanta helps teams develop potency and functional characterisation strategies that connect biological activity with product understanding and development requirements.
Potency & Functional Characterisation
Capabilities
Functional characterisation approaches
Potency strategy
Mechanism-of-action mapping
Surrogate markers
Matrixed potency approaches & assay design
Cellvanta helps connect product understanding, analytical evidence and technical development considerations to the wider CMC programme. Process and manufacturing changes can create uncertainty about whether a product has remained sufficiently consistent. We help teams develop analytical strategies that support comparability assessments and evolve alongside the product and process.
CMC, Analytical Lifecycle & Comparability
Capabilities
CMC strategy support
Comparability strategy
Analytical gap assessment
Analytical lifecycle strategy
CQA justification
Analytical bridging
Product characterisation around process changes
Reference material considerations
