Yantai – September 09, 2026 -- CelluPro has become the first Chinese cell culture media supplier to receive EXCiPACTTM GMP Certification for Pharmaceutical Auxiliary Materials, adding an internationally recognized quality benchmark to its biomanufacturing supply chain.
EXCiPACT Certification Validates Manufacturing Controls and Traceability
The EXCiPACTTM scheme sets GMP requirements for materials used in biopharmaceutical manufacturing, assessing quality management, manufacturing controls, traceability, and supply chain practices. CelluPro's certification adds to an existing compliance portfolio that includes ISO 9001, ISO 13485, ISO 14001, ISO 45001, and ISO 22301, covering quality management, environmental management, occupational health and safety, and business continuity.
Company Has Supported Three Commercial Projects for Global Pharma Partners
CelluPro has more than a decade of experience in cell culture media formulation and upstream bioprocessing. It has supported three commercial manufacturing projects for global multinational partners and has experience backing commercialized biopharmaceutical products through both FDA BLA and EMA submissions.
Product Platform Spans CHO, HEK293 and Cell and Gene Therapy Applications
CelluPro's manufacturing platform covers cell culture media production from process development through clinical and commercial manufacturing. Applications include CHO-based recombinant protein and antibody production, HEK293-based protein and viral vector production, and cell and gene therapy processes.
Certification Arrives as Biopharma Pipelines Move Toward Commercial Scale
As development pipelines progress from early research toward clinical and commercial manufacturing, cell culture media are being deployed across a broader range of activities, increasing demand for materials that meet quality, scalability, traceability, and regulatory requirements at later manufacturing stages. CelluPro is expanding its manufacturing and international supply capabilities to give biopharmaceutical manufacturers worldwide an additional GMP-grade sourcing option.