DRAFT TRANSLATION · REVIEW PENDING
PRODUCTION INFRASTRUCTURE
R&D · PRODUCTION INFRASTRUCTURE
PRODUCTION INFRASTRUCTURE
Building smart BGMP production infrastructure with global biotechnology standards in mind
HAEPAGEN is preparing a BGMP-aligned production foundation in the Hwasun Bio Industrial Complex for stable biomaterial manufacturing.
The facilities and equipment described on this page are currently under development or in preparation.01 · HWASUN PRODUCTION BASE
Developing a production base in the Hwasun Bio Industrial Complex
Based on an investment MOU with the regional and Hwasun authorities, HAEPAGEN is preparing a BGMP-aligned production foundation in the Hwasun Bio Industrial Complex.
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Production foundation in the Hwasun Bio Industrial Complex
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Development of a BGMP-aligned production facility
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Cleanroom plan for high-purity biomaterial purification
- 04
Preparation of a medical-grade biomaterial purification facility
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Precision HVAC plan designed to prevent cross-contamination
02 · ONE-STOP MANUFACTURING PROCESS
From raw-material sourcing to quality control and production
RAW MATERIAL
Jellyfish sourcing
PRE-TREATMENT
Pre-treatment and salting
EXTRACTION
Patented extraction
PURIFICATION
High-purity purification
QUALITY CONTROL
QA / QC
PRODUCTION
Biomaterial production
03 · QUALITY ASSURANCE / QA·QC
Preparing a verifiable quality framework alongside the production foundation
The following items describe the quality controls under consideration during preparation and do not imply completed certification or facility operation.
Batch Analysis
Batch-level high-purity collagen component analysis
Telopeptide Test
Residual telopeptide inspection
Contamination Control
Control systems designed to prevent cross-contamination
Standards Framework
A quality framework considering relevant CGMP, HACCP and GMP standards