Quality

Quality Assurance

Quality Management System (QMS)

STgen Bio's biopharmaceutical products are developed using a quality management system that ensures consistent quality and safety in accordance with cGMP regulations.

STgen Bio 에스티젠바이오 Tgen Bio 에스티젠바이오

Documentation System

STgen Bio’s document hierarchy is organized from Level 1 to Level 4, and all documents are managed under GMP regulations as part of the Document Life Cycle.

QM Level 1
SOP Level 2
Work Instruction Level 3
Forms, Records Level 4

"We place the highest priority on the well-being and health of patients and are committed to producing biopharmaceuticals of exceptional quality that instill trust and assurance." is the driving principle behind STgen Bio’s dedication to quality and to establish a continuous quality culture based on this principle.

To comply with GMP regulations and produce consistent quality biopharmaceutical products, Stgen Bio’s QA Team utilizes a systematic document management system to manage documents from issuance to approval, and storage. Additionally, through our Quality Management System, we record and control Corrective Action Preventive Action (CAPA) actions that may occur during manufacturing.

Furthermore, to ensure ongoing compliance with cGMP, we conduct regular training and data integrity assessments to maintain the integrity of our quality system.

With our unwavering dedication to quality and our robust quality control measures, STgen Bio guarantees the stability, safety, and efficacy of our products.

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Instrumental Analysis


Instrumental Analysis

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Sample / Stability


Sample / Stability

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Microbial / Bioassay


Microbial / Bioassay

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Quality Control

Our QC test area is composed of three distinct sections: Physical/Chemical Laboratory, Microbiology Laboratory, and Bioassay Laboratory, that are separated from the API and Fill and Finish production areas to more strictly and accurately control the quality of biopharmaceuticals. STgen Bio adheres to not only ICH and PIC/S GMP guidelines, but also the latest regulations and guidelines from Korea, Japan, US, and Europe, to conduct quality control on raw materials to final products.
Physical/Chemical Laboratory · Sample/Stability
HPLC
CE
ICP-OES
UV/Vis Spectrophotometer
Ion Chromatography
GC
The Physical/Chemical Laboratory utilizes various analytical equipment (e.g. HPLC, GC, ICP-OES, CE, UV/Vis spectrophotometer, TOC analyzer, pH/conductivity meter, etc.) to perform tests on raw materials, IPC/DS/DP, stability, finished products/consumables, and WFI (water for injection).

The Sample/Stability Team performs sample collection and sample management for quality testing. In addition, a comprehensive stability program is operated to oversee stability testing for each individual project.
Main test contents

Assays (e.g. UV/Vis, IR, etc.)

Chromatographic testing

Identification of active ingredients and impurities

Physicochemical determination

Limit tests (heavy metals, etc.)

Analysis of water for pharmaceutical purpose (TOC, conductivity)

Stability testing

Microbiology Laboratory · Bioassay Laboratory
RT-PCR System
Microplate Reader
Luminescence Microplate Reader
Incubator
Biosafety Cabinet
Endotoxin Detection System(MCS)
The Microbiology and Bioassay Laboratories performs cell-based potency assays, sterility tests, and microbial tests. Quality testing is conducted using PCR and ELISA for impurities.
Main test contents

Microbial limit testing

Sterility testing

Bacterial endotoxin testing

Bioburden testing

Microbiological tests in individual process media (air, water and technical gases)

Confirmation of personnel hygiene

Determination of microbiological exposure on clothing and hands of production personnel

EM (environmental monitoring)

Cell-based bioassay

Cytotoxicity (ADCC and CDC)

Other product-specific bioassays

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