Quality Certification Qualification Assurance
Backed by standardized production and rigorous quality control systems, all Anrate recombinant protein products are equipped with complete official qualifications and quality certifications. We have built a full-link quality assurance system covering production compliance, systematic management, product safety and mass production standards, fully meeting the compliance and access requirements for biopharmaceuticals, cell therapy, scientific research and other fields.
1. Pharmaceutical Production Compliance Qualification
Our parent company, Tonghua Anrate, holds the officially issued Pharmaceutical Production License and has built the world’s first integrated 100 kL fermentation and purification CMC standardized production line. The entire production line qualifies for commercial and large-scale pharmaceutical-grade manufacturing, with all procedures strictly complying with the highest production specifications of the biomedical industry.
2. Full-process GMP Quality Management System
The production base fully implements the GMP standardized management system, covering the entire process of R&D, fermentation, purification, filling, testing and warehousing. Supported by an intelligent quality management system, we realize traceable production data, controllable process parameters and early warning of quality deviations. It effectively eliminates batch fluctuations, ensures long-term product stability and consistency, and satisfies the compliance requirements for industrial mass production of pharmaceutical enterprises.
3. National-level Special Technical Endorsement
Our core recombinant protein technologies are key achievements of the national 12th and 14th Five-Year Major New Drug Creation Special Projects. The core craftsmanship, purification technologies and expression systems have passed national technical verification, with their technical maturity and compliance officially and authoritatively recognized.
4. International Market Access Qualifications
Our core recombinant human albumin has obtained international market access qualifications and been officially approved in multiple countries including Russia and Kyrgyzstan. Adopting internationally aligned quality standards, our products are fully compliant with global export and commercial supply requirements.
5. Animal-free Safety & Quality Control System
All cell culture grade products adopt100% animal-free and serum-free production processes with no animal-derived ingredients involved throughout production. This completely eliminates the risk of viral, pathogen and exogenous contamination at the source. In line with global high-end quality standards for animal-free and serum-free biomanufacturing, our products are perfectly applicable to high-precision scenarios including cell therapy, antibody drugs and vaccine development.
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