Our strength is to generate high-performance production cell lines under a target product profile by our proprietary CHO expression technologies. We are implementing state-of-the-art single cell printer and high-resolution imager to ensure monoclonality and to reduce the time of single cell cloning.
CELL LINE & PROCESS DEVELOPMENT
CELL LINE DEVELOPMENT
PROCESS DEVELOPMENT USP/DSP
A scalable platform technology that supports achievement of ideal protein product quality and yield
Eden Biologics has scalable platform technologies for cell culture and purification to provide optimal protein product qualities and yield. We develop processes in 3L and 50L, and then scale it up to 200L, 500L or 2,000L for use in non-clinical, clinical trials and commercial production.
Cell Culture Process Development (USP)
- CCPD develops robust processes suitable for GMP clinical and commercial manufacturing and process validation
- Our Process Development includes clone screening in bioreactors, media and feed development, defining optimal ranges for bioreactor operation and control parameters
- Supports process transfer into manufacturing and provide technical support
Step 1:
Lead clones from Eden Cell Line Development Group
Step 2:
Rapid preliminary assessment of cell growth, productivity and product quality
Step 3:
500mL & 3L scale – Comprehensive process development & characterization
Step 4:
50L scale – Process confirmation in GE XDR50
Step 5:
Full-scale – Commercial manufacturing in GE XDR500/2000
Purification Process Development (DSP)
Process Development, Optimization and Tech Transfer
- Standardized purification platform for mAb
- Process optimization for Viral Clearance (non-mAb project)
- Impurity removal optimization
- Improve yields and reduce costs
- Utilize purification equipment sufficiently to support up to 4 projects simultaneously
- Analytical team within group to support concurrent study
- Numerous PD documents to support Tech transfer
Clinical Research
- Generate material for animal study
Process Characterization-General
- Well established laboratory environment for process characterization
- Well maintained equipment and well controlled sample logistics tracking
- Trained personnel
- Personnel strictly follows GLP and GDP
Process Characterization-Process
- Risk based parameter range assessment and DOE in process modelling
- Statistics approach for data analysis
Cell Culture Supernatant (HCCF)
Chromatography
1 Capture + 1-3 Polish Steps
Viral Filtration
Ultrafiltration and Diafiltration
Final Filtration
Contact us to learn more!