INDUSTRIALIZATION
COST-EFFECTIVE
TIME-SAVING
As a Drug Developer, you are the expert of your specific ATMP Process.
As a valuable CDMO player, we are the right Partner to optimize critical aspects of your process, resulting in cost saving and more reliable products for patients.
Drug Development Phase
Discovery
Pre-Clinic
Clinic Phase I, II, III
Regulatory Compliance
ANSM
EMA
FDA
PFDA
Time to Market
GANTT Chart Optimization
Product Design
Adherent Cells : iPS cells, MSCs,…
Non-Adherent Cells : Leukocytes, Engineered cells (CAR-T, CAR-NK, CAR-Treg…)
ExtraVesicules : Exosomes…
Process Services
Process Review
Process Design
Process Transfer
Process Validation
Scalability
Scale-Out
Scale-Up
Automation
Cost drivers
Raw material
Manufacturing
Dose
Raw material
Hospital / Clinic contract
Tissue sourcing
Cell line handling
UpStream Process 1 Technology
2D culture
Bed-fixed
Hollow Fiber
3D _microcarrier
UpStream Process 2 Protocol
Standard
Chemical priming
Genetic priming
DownStream Process
Isolation
Harvesting
Washing
Filtration
Concentration
Formulation
Cryoconservation
Process limits
Critical Attributes (CQA & CMA)
Process Parameters (CPP & KPP)
Design Space
Data Acquisition
QbD_Quality by Design Approach
PAT_Process Analytical Technology Approach
Digitalization Approach
Data Analysis
Unimodal Data
Multimodal Data
Data minig
Analytical-base Approach
Cellnature
Cellsecure
Cellfeature
