Building Rigorous Programs for Manufacturing Success
We evaluate equipment, raw materials, and analytics up front, with fit-for-purpose controls and standards, before committing to a manufacturing path. Early-stage programs that skip this step often lock in a direction before the underlying biology and materials fit has been properly interrogated — a shortcut whose cost shows up later, at scale or at tech transfer. Interrogating these factors first sets the right foundation from day one.
Program Design Elements
- Plasmid design and small-scale plasmid generation
- Delivery and gene editing route evaluation and selection
- Raw material testing and selection
- Equipment testing and selection
- New equipment integration into existing workflows
- Assay establishment with development of controls and standards
- Tracking/trending data for process & analytics
OUR EXPERTISE
Wide-Ranging Modality Expertise
Cell Types
- Primary cells (T, NK, Myeloid, etc.)
- Stem & progenitor cells (HSC, PSC, MSC, etc.)
- Specialized cells (differentiated stem cells, primary therapeutic cells)
Product architecture
- Autologous
- Adherent
- Scale-up
- Allogeneic
- Suspension
- Scale-out
Engineering Capabilities
- Gene editing
- Viral delivery
- Non-viral delivery
- Cellular reprogramming
