The certification process provides an independent assessment of traceability and supply chain integrity, essential requirements for materials used in biopharmaceutical production. This new credential complements CelluPro’s existing quality framework, which includes ISO 9001, 13485, 14001, 45001, and 22301 standards. These systems collectively oversee the firm’s environmental, occupational health, and business continuity protocols.
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CelluPro Secures EXCiPACT Certification for GMP Cell Culture Media
Yantai-based CelluPro has become the first Chinese supplier of cell culture media to earn EXCiPACT certification for pharmaceutical auxiliary materials. This milestone validates the company's quality management and manufacturing controls against rigorous international standards, positioning the firm to better serve global biopharmaceutical clients navigating clinical and commercial scale-up.
As biopharmaceutical pipelines transition from research to commercial manufacturing, the demand for consistent, high-quality media has intensified. CelluPro utilizes a manufacturing platform designed to support processes ranging from CHO-based recombinant protein production to HEK293-based viral vector manufacturing and gene therapies. The company has already provided support for three commercial manufacturing projects for multinational corporations, assisting with regulatory submissions for both the FDA and EMA. By securing this certification, CelluPro expands its capacity to offer international partners a reliable, GMP-grade sourcing option, adding flexibility to global biomanufacturing supply chains.
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