YANTAI, China, Sept. 7, 2026 /PRNewswire/ — CelluPro, a biotechnology company focusing on serum-free cell culture media and bioprocess solutions, has achieved EXCiPACT™ GMP Certification for Pharmaceutical Auxiliary Materials (PAMs), marking the first instance of a Chinese cell culture media supplier receiving this certification.
EXCiPACT™ is an internationally recognized certification scheme for pharmaceutical auxiliary materials, setting GMP standards for materials used in biopharmaceutical manufacturing. This certification provides an independent framework to assess quality management, manufacturing controls, traceability, and supply chain practices. For suppliers of cell culture media, EXCiPACT™ certification signifies an internationally recognized standard for GMP manufacturing and quality management.
The certification enhances CelluPro’s existing cGMP-compliant quality system, which is supported by certifications in ISO 9001, ISO 13485, ISO 14001, ISO 45001, and ISO 22301. These certifications encompass quality management, environmental management, occupational health and safety, and business continuity, showcasing CelluPro’s dedication to quality and sustainability in serving biopharmaceutical partners globally.
As biopharmaceutical innovation expands, development pipelines are increasingly moving from early research to clinical and commercial manufacturing. This shift fuels demand for cell culture media that ensure consistent performance throughout development while adhering to the quality, scalability, traceability, and regulatory requirements of later-stage manufacturing.
With over a decade of experience in cell culture media formulation and upstream bioprocessing, CelluPro creates products for various biopharmaceutical applications and cell culture processes. Their manufacturing platform supports the production of cell culture media from process development to clinical and commercial manufacturing, covering applications such as CHO-based recombinant protein and antibody production, HEK293-based protein and viral vector production, and cell and gene therapies.
CelluPro has successfully supported three commercial manufacturing projects for global MNC partners and has experience in backing commercialized biopharmaceutical products through both FDA BLA and EMA submissions.
As the global biopharmaceutical industry diversifies its process development and manufacturing needs, CelluPro is expanding its manufacturing and international supply capabilities to offer biopharmaceutical manufacturers worldwide an additional source of GMP-grade cell culture media, enhancing flexibility in global sourcing.
