cGMP MANUFACTURING
- Quality assurance
- Support for meetings with regulatory agencies
- Support for documentation submission and audits
- Navigating through the standards and needs of the various agencies.
- Knowledge of the regulations and guidance applying to clinical trials
- Validation, certification of equipment, supplies, processes
- Batch release and certification
- Storage
- Shipping logistic and distribution
- Production
- Validation
- QC testing
- Release testing and certification
- Batch recall
- QA and monitoring
CELL ISOLATION, CULTURE & CHARACTERIZATION
CELL SEPARATION, EXPANSION AND DIFFERENTIATION FACTORS
- T cell culture, stimulation, differentiation.
- DC differentiation, activation and loading
- NK cell culture
- Tumor cell isolation, culture, digestion
DEVELOPMENT OF COST-EFFECTIVE CELL CULTURE CONDITIONS
- Cell purity analysis
- Phenotype characterization
- Specification testing and functional validation
SCALE-UP PROCESS DEVELOPMENT AND OPTIMIZATION
- Technical transfer from customer conditions
- Comparability studies
- Bioprocess design, specification & testing
- Bioprocess scale-up & optimization (efficiency, closed system)
- Development of Cost-effective Strategies
- Process standardization and validation
- Critical parameter definition
- Stability studies
- Transport optimization