Yantai – September 09, 2026 -- CelluPro has secured EXCiPACTTM GMP certification for pharmaceutical auxiliary materials, becoming the first China-based cell culture media supplier to achieve the credential.
CelluPro adds EXCiPACT GMP to existing ISO certification portfolio
The biotechnology firm, which specializes in serum-free cell culture media and bioprocessing solutions, now holds EXCiPACTTM certification alongside ISO 9001, ISO 13485, ISO 14001, ISO 45001 and ISO 22301 certifications covering quality management, environmental management, occupational health and safety, and business continuity.
EXCiPACT sets internationally recognized GMP benchmark for pharmaceutical excipients
EXCiPACTTM is an internationally recognized certification scheme for pharmaceutical auxiliary materials that establishes Good Manufacturing Practice requirements for materials used in biopharmaceutical manufacturing. It provides an independent framework to assess quality management, manufacturing controls, traceability and supply chain practices.
CelluPro has supported three commercial manufacturing projects for global MNC partners
The company has more than a decade of experience in cell culture media formulation and early-stage bioprocessing, developing products for CHO cell-based recombinant protein and antibody production, HEK293 cell-based protein and viral vector production, and cell and gene therapy applications. CelluPro has supported commercialized biopharmaceutical products through both FDA BLA and EMA submissions.
Company expands manufacturing and supply capacity as biopharma demand shifts to commercial scale
As biopharmaceutical development projects increasingly move from early research and process development into clinical and commercial manufacturing, demand is rising for cell culture media that deliver consistent performance while meeting quality, scalability, traceability and regulatory requirements at later manufacturing stages. CelluPro is expanding its manufacturing and international supply capacity to offer biopharmaceutical manufacturers worldwide an additional source of GMP-certified cell culture media and greater flexibility in global sourcing.