Better development decisions start with deeper process understanding. Through an integrated Process Development (PD) and Analytical Development (AD) ecosystem, we combine advanced characterization, manufacturing expertise, and data-driven decision making to establish robust and scalable processes across autologous, allogeneic, and iPSC-based programs.
Turning Insights into Development Decisions
By combining process development and analytical expertise, we generate the process understanding needed to guide development decisions with confidence. Advanced characterization, manufacturing awareness, and data-driven insights help establish robust and scalable processes across diverse cell therapy modalities. Together, these capabilities help inform process optimization, comparability strategies, and manufacturability decisions throughout development.
Explore Our Approach
- Whitepaper: De-risking & Streamlining Cell & Gene Therapy Development Through Advanced PD/AD Strategies >
- Poster: Turning Development Insights into GMP-Ready Processes >
Our Process & Analytical Development Capabilities
Process Development
Developing manufacturing processes with scalability and control in mind.
Our process development teams establish and optimize manufacturing workflows across multiple cell therapy modalities, focusing on process performance, manufacturability, and future clinical requirements.
Capabilities include:
- 2D and 3D cell expansion
- Differentiation workflows
- Process scale-up strategies
- Closed-system processing and handling
- Manufacturing support
Cell Engineering & Gene Editing
Supporting increasingly sophisticated cellular engineering strategies.
We support gene-edited and engineered cell therapy products through genome modification, clonal isolation, characterization, enrichment, and process integration activities designed to advance development and manufacturing objectives.
Capabilities include:
- Gene editing (KO/KI strategies)
- Single-cell cloning & seeding
- Clone screening and selection
- Cell sorting and enrichment
- Cell purification workflows
Analytical Development & Product Characterization
Building analytical understanding to support process development and clinical progression.
A robust analytical strategy is essential for demonstrating product identity, purity, potency, and comparability. Our teams develop and implement analytical methods that strengthen process understanding and support evolving regulatory expectations.
Capabilities include:
- Analytical method development
- Cell based assay (identity, purity, potency)
- qPCR and molecular characterization
- Process support analytics
Preserving Knowledge Across Development
A common challenge in cell therapy development is the loss of process knowledge and analytical insights as programs move between functions and stages. By operating within a broader integrated development environment, insights generated during process and analytical development can be carried forward to support manufacturing readiness, quality activities, and future clinical progression.
Continue your development journey with our integrated cell therapy CDMO capabilities and explore our related CDMO offering.
