In a landmark achievement for China’s biotech sector, CelluPro has secured EXCiPACT Certification, signaling a major leap forward in the quality assurance of its serum-free cell culture media. This coveted GMP accreditation places the company among a select group of global suppliers adhering to rigorous Pharmaceutical Auxiliary Materials standards, and cements its reputation as a trusted partner for biopharmaceutical manufacturers worldwide.
EXCiPACT Certification brings an independent framework for assessing quality management, manufacturing controls, traceability, and supply chain integrity. By meeting these standards, CelluPro’s GMP-grade media production is now verified against internationally recognized benchmarks, complementing its existing ISO 9001, 13485, 14001, 45001, and 22301 credentials. This comprehensive quality ecosystem underscores the company’s commitment to operational excellence and regulatory compliance.
The timing of this certification aligns with accelerating demand for reliable cell culture supply throughout the biopharmaceutical lifecycle. As promising pipelines transition from discovery to clinical and commercial scale, consistent performance and traceability in media formulation become critical. CelluPro’s portfolio—spanning CHO-based antibody production, HEK293-derived viral vectors, and advanced cell and gene therapies—demonstrates the company’s technical depth and its ability to meet diverse process requirements.
With over a decade of formulation and upstream bioprocess expertise, CelluPro has already contributed to multiple FDA BLA and EMA submissions and supported three commercial manufacturing initiatives for leading global partners. From our perspective, the new certification not only expands capacity but also offers a strategic hedge against supply-chain disruptions, giving clients added confidence in sourcing GMP-grade media from Asia.
In conclusion, CelluPro’s EXCiPACT Certification represents more than a quality milestone—it reflects the maturation of regional biomanufacturing capabilities and the growing importance of robust supplier qualification. As biopharma innovation thrives, having an internationally certified, scalable cell culture media source will help drive reliable and cost-effective production across the globe.
