cGMP Production for clinical trials
Including microbial fermentation, mammalian cell culture and downstream processing
Filling & Packing Line
An automatic sterile fill and finish for vials, cartridges, and pre-filled syringes
Biopharmaceutical Manufacturing Process Development
Well equipped process development lab for Upstream and Downstream process optimization, in process analysis and scaleup from flasks to 10L fermentation/cell culture.
Technology Transfer
Experienced team of scientist for intra-site and inter-site technology transfer for biologics. Gap-analysis, risk assessment and mitigation, process trouble shooting and Technology Transfer documentation.
CORE TECHNOLOGY
KINGEN BIOTECH INNOVATION PLATFORM
BIOPROCESS ENGINEERING
• Fermentation
E. coli, yeast, etc
• Cell Culture
VERO, CHO cells, etc
• Downstream Processing
TFF, Chromatography
PHARMACEUTICAL SCIENCE
• Formulation
• Lyophilization
• Stability studies
• Analytical methods
REGULATORY SCIENCE
• Qualification and validation
• Dossier preparation
• Regulatory requirement