ISU ABXIS is committed to excellence in manufacturing innovative biological therapeutics under global GMP(Good Manufacturing Practice) compliance and delivers the development and manufacturing solutions to our business partner.
GMP certified manufacturer facility
The facility with the capability to produce 3 different products simultaneously
High quality and high productivity in a manufacturing system with various culture methods
Utilize single-use bioreactor for production stability
Provide CDMO service tailored to each project ranging from 20 to 1,000L
Avoid the risk of contamination by adopting the single-use system (WAVE Bioreactor, RM Bioreactor, Sing-Use Bioreactor)
Manufacturing capability of biological products use in preclinical study, clinical trials, and commercial supply with the capacity range from 20 to 1,000L
Established efficient manufacturing system with availability in perfusion, fed-batch, and batch culture runs
Downstream Process
Established system in order to optimize purification process includes column chromatography and virus nanofiltration
Use of downstream processing equipment that allows the production for biological use in preclinical study, clinical trial, and commercial supply
Utility System
Maintain the infrastructure that support production through monitoring on manufacturing water and air conditioning which are controlled by an automation and real-time control system
Quality Control
Maintain accuracy and data integrity in quality control by using the latest electronic systems Lab Information Management System (LIMS) and Electronic Lab Note (ELN)
Perform product quality inspections and analytical testing on samples from drug substances (DS) to drug products (DP)
Use of validated analytical equipment including chemical, biochemical, microbiological, and stability testing
Quality Assurance
Consistent product production with a focus on product quality by establishing the Validation Master Plan(VMP)
Experienced in inspections and assessments of manufacturing facility by numerous government regulatory agencies