SERVICES – KinGen Biotech

YOUR PARTNER TO ACCELERATE DRUG DEVLOPMENT TO REACH A POPULATION OF 600 MILLION.

Our highly committed team consists of more than 100 scientists, engineers, pharmacists, and technicians who are ready to serve specific needs of our clients in 4 key services:

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

SCALE UP STUDIES

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

GMP

REGULATORY SCIENCE

• Qualification and validation
• Dossier preparation
• Regulatory requirement

GMP FACILITIES

Unit 1-Microbial Bioprocess

• USP Fermentation: 500L
• DSP Chromatography, TFF
• BSL2-compliant

Unit 2-Cell Culture Bioprocess

• USP Cell culture: 500L,
• DSP Chromatography, TFF
• BSL2-compliant

Unit 2.1-Vial Filling Line

• Vial filling, 6000 objects per hour
• Lyophilization

Unit 3-Versatile Filling Line (Ready in 2021)

• Vials
• Pre-filled syringes
• Cartridges

DOCUMENTATION SYSTEM

At KinGen Biotech, we have well established documentation system including site master files, quality manuals, site validation master plans, PM/calibration plans, 454 SOPs , 120 WIs, 801 protocols, 247 specifications, 45 test methods, and MFs/BMRs as well as archiving systems. Computerized documentation system validation is planned in the future, and an ISO9001 certification is planned in 2021.

VALIDATION

Our validation system includes site validation master plan, qualification (IQ/OQ/PQ) of all manufacturing and QC equipment as well as of clean utility systems, PM and calibration plan, analytical method validations. Validation facilities available in-house include temperature-related activities and cleanroom qualifications.