Yantai, China – September 09, 2026 -- CelluPro has secured EXCiPACTTM GMP certification for pharmaceutical auxiliary materials, becoming the first Chinese cell culture media supplier to receive the internationally recognized credential.

EXCiPACT certification validates GMP compliance for biopharma raw materials

The EXCiPACTTM program sets GMP requirements for materials used in biopharmaceutical manufacturing, assessing quality management, manufacturing controls, traceability and supply chain practices. For cell culture media suppliers, the certification serves as an internationally recognized benchmark for GMP-compliant production and quality management.

New certification adds to CelluPro's existing quality framework

The credential builds on CelluPro's current Good Manufacturing Practices (cGMP) system, which already includes ISO 9001, ISO 13485, ISO 14001, ISO 45001 and ISO 22301 certifications covering quality management, environmental management, occupational health and safety, and business continuity.

CelluPro has backed three commercial manufacturing projects for multinational partners

The company, which has more than a decade of experience in cell culture media formulation and upstream bioprocessing, has supported three commercial manufacturing projects for multinational partners. It has also assisted commercialized biopharmaceutical products through both FDA Biologics License Application (BLA) and EMA submission processes.

Product platform spans CHO and HEK293 cell applications

CelluPro's manufacturing platform covers cell culture media production from process development through clinical and commercial manufacturing, with applications including recombinant protein and antibody production from CHO cells, protein and viral vector production from HEK293 cells, and cell and gene therapy.

As biopharmaceutical development shifts more projects from early-stage research toward clinical and commercial manufacturing, demand has grown for culture media that deliver consistent performance while meeting quality, scalability, traceability and regulatory requirements at later manufacturing stages. CelluPro is expanding its global production and supply capabilities to give biopharmaceutical manufacturers an additional GMP-compliant media source and greater flexibility in global sourcing.