Bio Production

We are an unparalleled biopharmaceutical company.

Osong Plant

오송공장 사진
오송공장 사진
오송공장 사진
오송공장 사진
오송공장 사진
  • No. of Employees379
  • Constructed on Apr. 2018
  • Ground Area42,318.3㎡
  • Floor Area52,247㎡

1Annual API Production Capacity ≥ 3,000 kg

2Comparable to the capacity of 300,000L fed-batch culture plants*

3Four 2,700L Continuous Perfusion Culture Bioreactors and Four Purification

4Capable of producing liquid, lyophilized, prefilled syringes, and final packaging

* Assumed 2 g/L production
** As of Nov. 2022

General Manufacturing Process

Raw Materials
Arrow
Cell Culture
Arrow
Purification
Arrow
Fill Finish
Arrow
Release
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Shipment

Quality Assurance

Quality Assurance establishes and operates a robust quality system to ensure drug quality derived from product safety and efficacy as well as data integrity with respect to the entire lifecycle of a drug, starting from early research to post-market surveillance, to lay the foundation for production.
Compliance
Investigation
Validation
Audit
Document Control
Risk Management

Quality Control

In order to manufacture consistent and high-quality drugs, Quality Control performs various analytical tests, based on pharmacopeia and guidelines of various regulatory entities, for raw materials, production environment, intermediate drugs, and final drug products and maintains drug stability through periodic examinations of the drug products properties.
Raw Material Testing
Physicochemical Testing
Biological Testing
Microbiological Testing
Stability Testing
Clean Utility / Environmental Monitoring

Production Management

Production Management forms the foundation to all production activities through procuring and storing materials used in the process and provides a high-level schedule for production. Warehouse also controls all materials that flow in and out of the facility starting from chemical ingredients to biomedical wastes to commercial drug.
Production Scheduling
Procurement
Raw Material Receival
Raw Material Management
Weighing and Dispensing
Product Shipping

Upstream Manufacturing

Upstream Manufacturing marks the starting point of production for the principal ingredient of the final drug through expanding the producing cell, from seed cell culture to main cell culture, and ultimately to product harvest. A strict and rigorous control of the process is demanded for a consistent quality product due to the highly sensitive and volatile nature of growing the living organism.
Cell Preparation
Media Preparation
Seed Culture
Main Culture
Culture Monitoring
Product Harvest

Downstream Manufacturing

The harvested culture fluid contains various impurities such as cellular debris, heavy metals, viruses, and microorganisms, in addition to the desired target protein. Downstream Manufacturing purifies the harvested fluid of such impurities through multiple steps such as ion exchange, product-specific chromatography, diafiltration, ultrafiltration, concentration, and other treatment processes to ensure that only the pure target proteins remain and assure product safety.
Buffer Preparation
Chromatography
Virus Control
Impurity Control
Ultrafiltration / Diafiltration
Bulk Fill

Fill Finish

As the filling and finishing process of a drug is the last step that involves drug manipulations, a strict process control is critical to ensure patient safety. Fill Finish stringently controls the process through drug formulation, filling, lyophilization, capping, foreign material inspection, labeling, and packaging. Filling processes that require sterile maintenance are performed in a Restricted Access Barrier System (RABS), which limits safety critical intervention.
Primary Package Preparation
Product Formulation
Aseptic Filling
Primary Package Closure
Product Inspection
Secondary Packaging

Engineering

Engineering is vital for producing consistent quality products through preventative maintenance and calibration of production equipment for reliable operation. Engineering manages the core utilities such as water, gas, electrical system as well as the facility as a whole and establishes the foundation for stable production.
Installation Verification
Equipment Calibration
Equipment Maintenance
Hazard Control
Infrastructure Management
Utility Management