RESOURCES & INSIGHTS
Resources, insights and perspectives at the intersection of science, execution and capital.
Thoughts on development, regulation, investment, our reading and the wider conversation across ecosystems.
FEATURED INSIGHT
Why you should measure comparability debt before ever starting a study
Comparability studies reveal technical uncertainty that can accumulate much earlier in an advanced therapy programme. This perspective published in Cell&Gene explores how analytical capability, process understanding and reference materials shape the ability to demonstrate comparability when manufacturing or analytical changes eventually occur. The perspective was also featured by One Nucleus and Bionow.
FEATURED INSIGHT
The development gap
A perspective on potency strategy, manufacturing readiness, comparability planning and investment pressures across advanced therapies.
RESOURCE
Bridging science, execution and capital in biotech
A perspective on translational readiness, analytical maturity, technical diligence and upstream coordination across advanced therapies and how Cellvanta can help.
RESOURCE
Cellvanta capability overview
An overview of the development challenges Cellvanta helps organisations navigate, representative situations where we get involved and examples of relevant experience.
ON LINKEDIN
Recent perspectives, shorter form.
A curated selection of recent posts from our LinkedIn presence. Observations on biotech development and the wider ecosystem. Follow Cellvanta for the full stream.
INVESTMENT & RISK
When flow cytometry becomes the regulatory decision-maker.
For cell and gene therapies, regulators no longer ask whether you have flow data, they ask whether it's fit for purpose. The gap between research-grade flow and decision-grade flow is where many CMC packages wobble, and increasingly where investors are taking notice.
CMC STRATEGY
Flow cytometry that holds up under CMC and regulatory pressure.
Marker selection, defensible gating, variability control and matrixed potency are practical considerations that determine whether a flow cytometry panel survives scale-up. A view on designing assays that don't just look good in development, but support confident decisions across CMC and comparability.
CMC STRATEGY
Potency in cell therapy is a strategy, not an assay.
High-dimensional flow cytometry can capture functional heterogeneity, MOA signatures and batch-to-batch consistency — but only when panels are designed with biology, feasibility and regulatory alignment in mind. A view on treating potency as a strategy from first clinical batch onward.