CMC Compliance
Advanced Characterization and Biocompatibility Evaluation System
Core Bioprocess and Production Capacity
Our proprietary downstream processing achieves >99.9% purity for medical-grade collagen. The products possess superior thermostability and structural integrity, resolving stability issues common in traditional biomaterials. Class 10,000 and Class 100 cleanrooms ensure industrial scalability.
We strictly adhere to GMP standards. Refined CMC (Chemical, Manufacturing, and Controls) management ensures stable, reliable large-scale manufacturing of high-quality, safe products.
We employ a multi-dimensional quality control system (from primary sequence to 3D structure) using Orbitrap MS, LC-MS/MS, SEM/TEM, and other advanced instruments. Comprehensive toxicology and biocompatibility testing ensure products are endotoxin-free and pyrogen-free.
