CELL LINE & PROCESS DEVELOPMENT

CELL LINE DEVELOPMENT

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 Development

PROCESS DEVELOPMENT USP/DSP

A scalable platform technology that supports achievement of idea protein product quality and yeild

JHL have 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)

  • CCDP develops robust processes suitable for GMP clinical and commercial manufacturing and process validation
  • Our Process Development includes clone screning in bioreactors, media and feed development, defining optimal ranges for bioeactor operation and control parameters
  • Supports process transfer into manufacturing and provide technical support

Step 1:

Lead clones from JHL Cell Line Development Group

Lead Clones from Cell Line Development

Step 2:

Rapid preliminary assessment of cell growth, productivity and product quality

Shake Flask Studies

Step 3:

500mL & 3L scale – Comprehensive process development & characterization

3L Scale Process Development

Step 4:

50L scale – Process confirmation in GE XDR50

50L Scale GE XDR50

Step 5:

Full-scale – Commercial manufacturing in GE XDR500/2000

2000L Scale GE XDR2000

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

AKTA AVANT Chromatography : 1 Capture + 1-3 Polish Steps
Crossflow Ultrafiltration and Diafiltration
AKTAPilot
AKTA PURE Chromatography : 1 Capture + 1-3 Polish Steps
Contact us to learn more!