Comprehensive Service Capabilities
01
Research & Preclinical Development
- Feasibility studies and target validation
- Cell line development
- Viral vector development (AAV, lentivirus)
- Device concept prototyping
- Preclinical study support
02
Formulation Development
- Biologics formulation (proteins, mAbs)
- Cell & gene therapy formulation
- Injectable and lyophilized products
- Device-compatible formulations
- Stability studies
03
Analytical Development & Testing
- Method development and validation
- Characterization of biologics and vectors
- Potency assays
- Extractables & leachables
- Microbiology testing
04
Process Development & Scale-Up
- Upstream & downstream development
- Vector production scale-up
- Tech transfer
- Continuous improvement
05
GMP Manufacturing
- Clinical & commercial manufacturing
- Biologics production
- Cell therapy processing
- Fill-finish
06
Quality & Regulatory Services
- cGMP systems
- IND, BLA, NDA support
- 510(k), PMA support
- Audit readiness