Development Services
Translational Experience Applied to Your Program
A promising cell technology is not yet a therapeutic product. Moving from biological concept to clinical development requires coordinated decisions across cell biology, process development, characterization, preclinical evidence, manufacturing, regulatory strategy and clinical design.
Decinova supports organizations navigating this transition. Our development capabilities originate from hands-on experience advancing our own cell-therapy platform through these same challenges.
Who We Work With
Support Across the Development Ecosystem
Support can range from focused scientific assessment to integrated development programs.
Development Capabilities
Six Areas of Integrated Development Support
Platform & Product Assessment
Evaluate the scientific rationale, translational maturity, critical development gaps and potential path from research platform to therapeutic product.
Potential scope includes
- Biological rationale
- Target indication
- Product concept
- Competitive differentiation
- Translational gaps
- Development risks
- Development roadmap
Preclinical Development
Build a preclinical strategy around the questions required to advance the product rather than generating disconnected experiments.
Potential scope includes
- Proof-of-concept strategy
- Relevant model selection
- Pharmacology planning
- Biodistribution considerations
- Safety & toxicology strategy
- Dose rationale
- Study sequencing
- Preclinical development packages
Process & Manufacturing Development
Translate a research cell process toward a reproducible therapeutic-manufacturing strategy.
Potential scope includes
- Starting-material strategy
- Isolation & expansion
- Cell banking
- Process optimization
- Scale-up considerations
- Cryopreservation
- Product handling
- Manufacturing workflow
- GMP translation strategy
Characterization, QC & Potency
Define what the product is and how its critical biological properties can be consistently assessed.
Potential scope includes
- Identity
- Purity
- Viability
- Phenotype
- Functional characterization
- Potency strategy
- Release-testing concepts
- Stability considerations
- Comparability strategy
Regulatory Development Strategy
Integrate scientific and manufacturing development with the evidence expected for clinical translation.
Potential scope includes
- Development-gap assessment
- Regulatory roadmap
- Preclinical package strategy
- CMC readiness
- Clinical-development documentation strategy
- Regulatory interaction preparation
Regulatory services are strategic and developmental in nature and do not constitute legal or regulatory-agency representation unless specifically agreed through qualified partners.
Clinical Development
Design a clinical strategy capable of answering the questions required for subsequent development.
Potential scope includes
- Indication strategy
- Target population
- Dose & administration rationale
- Protocol-development support
- Endpoint strategy
- Safety monitoring
- Clinical-development sequencing
- Translational biomarker considerations
Our Difference
Development Advice From People Who Have Developed Cell Therapy
Decinova’s approach was shaped through the development of DSC. That experience has involved the practical challenges of cell sourcing, expansion, cryopreservation, characterization, preclinical development, clinical administration, manufacturing and regulatory progression.
We therefore evaluate programs as interconnected therapeutic-development systems — not as isolated scientific, manufacturing or regulatory tasks.
Engagement Models
Projects Can Be Structured As:
Development Assessment
A focused review identifying gaps, risks and priorities.
Development Roadmap
A structured plan from the program’s current stage to its next major value inflection point.
Integrated Development Program
Ongoing scientific and translational support across multiple development functions.
Expert Advisory
Targeted senior-level input on specific cell-therapy development challenges.
Technology Transfer Program
Development and implementation of a cell platform at a partner facility. See Technology Development →
Start With the Development Question
Tell Us Where Your Program Stands
Tell us what technology you have, where the program stands today and what milestone you need to reach next. We will determine whether Decinova can add meaningful value — and where.