OUR SERVICES
We Support Your Cell and Gene Product Development
.
From pre-clinical to cGMP manufacturing
Exoscan
In-depth scan of your current process and its clinical and commercial potential.
Development plan for fast-track timing to clinical phase, while preparing commercial phase competitiveness.
- EProcess and data analysis
- ERisk and gap identification
- ETechnology comparison and selection
- ECost modelling
Development
Process optimization, development and scale-up using a bioprocess and technology-driven approach.
Design of Experiment to achieve cost effectiveness & high performance viral manufacturing.
- EPlasmid design and production*
- EUSP and DSP process optimization and development
- EAnalytical transfer, bridging and development*
- ECell line and media optimization / re-selection*
- EManufacturing of non-GMP and toxicology materials
- EProcess scale-up
- EFormulation development*
- EDispensing into vials
- EStorage and product delivery
GMP Manufacturing
On-demand manufacturing for clinical and commercial needs.
- EHQ Grade or GMP Plasmid manufacturing*
- EGMP banking: MCB, MVS, WCB and WVS*
- EGMP manufacturing, testing and release services
- EFill & finish
- EStorage / product delivery*
- EStability studies on Drug Substance and Drug Product*
* supported in whole or in part by partner company
Exoscan
In-depth scan of your current process and its clinical and commercial potential.
Development plan for fast-track timing to clinical phase, while preparing commercial phase competitiveness.
- EProcess and data analysis
- ERisk and gap identification
- ETechnology comparison and selection
- ECost modelling
Development
Process optimization, development and scale-up using a bioprocess and technology-driven approach.
Design of Experiment to achieve cost effectiveness & high performance viral manufacturing.
- EPlasmid design and production*
- EUSP and DSP process optimization and development
- EAnalytical transfer, bridging and development*
- ECell line and media optimization / re-selection*
- EManufacturing of non-GMP and toxicology materials
- EProcess scale-up
- EFormulation development*
- EDispensing into vials
- EStorage and product delivery
GMP Manufacturing
On-demand manufacturing for clinical and commercial needs.
- EHQ Grade or GMP Plasmid manufacturing*
- EGMP banking: MCB, MVS, WCB and WVS*
- EGMP manufacturing, testing and release services
- EFill & finish
- EStorage / product delivery*
- EStability studies on Drug Substance and Drug Product*
* supported in whole or in part by partner company