About Us

GMP Facility

Facility Overview

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

Our GMP Facility

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Upstream Process

  • We avoid the risk of contamination by adopting the single-use system (WAVE Bioreactor, RM Bioreactor, Sing-Use Bioreactor).
  • We offer production for biologics use in preclinical study, clinical trials, and commercial supply capacity range from 20 to 1,000L.
  • We provide efficient manufacturing system with availability in perfusion, fed-batch, and batch culture runs.

Downstream Process

  • We have an established system in order to optimize purification process includes column chromatography and virus nanofiltration.
  • We have entire range of downstream processing equipment that allows the production for biologics use in preclinical study, clinical trial, and commercial supply.

Utility System

  • We 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

Quality Assurance