CelluPro Becomes First Chinese Media Supplier to Earn EXCiPACT Certification
Yantai-based CelluPro has secured EXCiPACT GMP certification for its pharmaceutical auxiliary materials, marking a milestone as the first Chinese cell culture media supplier to meet this international standard. The move bolsters the company’s ability to supply biopharmaceutical manufacturers navigating the transition from clinical research to commercial production.
The EXCiPACT scheme provides an independent framework for auditing quality management, manufacturing controls, and supply chain traceability. By aligning its operations with these requirements, CelluPro adds a critical layer of regulatory assurance to its existing cGMP-compliant system, which already holds ISO 9001, 13485, 14001, 45001, and 22301 certifications.
As biopharmaceutical pipelines mature, the demand for consistent, scalable media grows. CelluPro, with over a decade of experience, currently supports projects ranging from CHO-based recombinant protein production to HEK293-based viral vector manufacturing. The company has already contributed to three commercial manufacturing projects for multinational partners, providing support for products undergoing FDA BLA and EMA submissions. This latest certification positions the firm to offer international manufacturers greater flexibility and a more robust supply chain for their late-stage bioprocessing needs.
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