Bridging science, execution and capital in biotech
Technical diligence, development strategy and execution intelligence for advanced therapies.
THE DEVELOPMENT GAP
Strong science does not guarantee successful development.
Across advanced therapies, programmes stall not because the biology fails, but because of analytical fragility, comparability risk, manufacturing constraints and investment uncertainty.
Analytical fragility
Assays that don’t translate into reliable decisions.
Comparability risk
Changes that create regulatory and clinical uncertainty.
Manufacturing constraints
Processes that don’t scale or sustain.
AI is not execution
Models inform. Execution delivers — and the gap between pilot and scale is wider than most teams expect.
WHERE WE ADD VALUE
We help you navigate the gap between breakthrough and impact.
Built across science, execution, capital and connection to support better decisions and stronger programmes.
Development strategy
Hands-on advisory across CMC strategy, analytical development, comparability and lifecycle planning from research into clinic.
Technical diligence
Assessment of platform technology, manufacturing readiness and execution risk benchmarked against TRL and MRL frameworks, with AI-aware judgement on modern biotech.
WHO WE WORK WITH
Supporting organisations navigating complex development and adoption decisions.
Founders & Emerging Biotechs
Preparing for financing, partnerships, technical milestones and development decisions where execution risk can materially affect outcomes.
Technology & Platform Developers
Supporting adoption, positioning and readiness assessment for technologies intended to enable advanced therapy development.
CDMOs, Institutions & Ecosystem Partners
Helping organisations evaluate readiness, identify risk and strengthen decision-making across complex development pathways.
HOW CELLVANTA CAN HELP
01 Product Understanding
Support for programmes seeking to understand which product attributes matter, how they should be measured, and how they support development decisions.
Product characterisation strategy
CQA identification workshops
Comparability readiness reviews
Analytical gap assessments
Development risk reviews
Are we measuring the right CQAs?
Which attributes are actually driving our development decisions?
What evidence supports our current product definition?
What comparability risks are we creating today?
Typical questions
02 Cell Therapy Assay Development
Support for development of analytical methods used for product characterisation, process understanding and release.
Flow cytometry panel design
Marker selection strategy
Assay troubleshooting
Qualification planning
Technology transfer readiness
Analytical method reviews
Typical questions
Which assays should we prioritise for qualification?
Is this assay sensitive enough to detect process change?
Are we measuring biology or process artefacts?
What analytical gaps could delay development?
03 Potency & Regulatory Defensibility
Support for teams building a pathway from biological mechanism to defensible potency approaches.
Potency strategy reviews
Mechanism-to-assay mapping
Surrogate marker assessment
Matrix potency approaches
Comparability impact assessments
Typical questions
What are we actually measuring?
Which assay best reflects mechanism?
How do we move from discovery assay to release assay?
Would regulators accept this potency rationale?
TYPICAL ENGAGEMENTS
Focused projects designed to answer critical development or readiness questions.
Analytical & CMC Strategy Review
A rapid, independent review/development of specific analytical strategy, defined CMC risk evaluation and development readiness, designed to inform a critical decision scoped to a timeline.
TRL & MRL Readiness Assessment
A structured benchmarking review of platform, manufacturing and clinical readiness, calibrated to TRL and MRL frameworks for investment, partnership or grant decisions, scoped to a timeline.