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.
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.
"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.
* Click on the menu name.
Instrumental Analysis
Instrumental Analysis
Sample / Stability
Sample / Stability
Microbial / Bioassay
Microbial / Bioassay
Quality Control
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.
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
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
0%