CelluPro Achieves EXCiPACT™ GMP Certification
News related to:CelluPro · 2 min read
YANTAI, China, Sept. 7, 2026 /CourierPR/ -- CelluPro, a biotechnology company specializing in serum-free cell culture media and bioprocess solutions, has achieved EXCiPACT™ GMP Certification for Pharmaceutical Auxiliary Materials (PAMs), becoming the first Chinese cell culture media supplier to earn this international recognition. This certification underscores CelluPro’s commitment to maintaining the highest standards of quality and manufacturing practices in the biopharmaceutical industry.
EXCiPACT™ is an internationally recognized certification scheme that establishes Good Manufacturing Practice (GMP) requirements for materials used in biopharmaceutical manufacturing. It provides an independent framework for assessing quality management, manufacturing controls, traceability, and supply chain practices. With this certification, CelluPro not only meets the stringent quality requirements of the pharmaceutical industry but also strengthens its global biomanufacturing supply capabilities.
The EXCiPACT™ certification complements CelluPro’s existing quality management systems, which are ISO 9001, ISO 13485, ISO 14001, ISO 45001, and ISO 22301 certified. These certifications cover a wide range of areas including quality management, environmental management, occupational health and safety, and business continuity. Together, they support CelluPro’s comprehensive quality and sustainability practices, ensuring that it can serve biopharmaceutical partners worldwide.
CelluPro has over a decade of experience in cell culture media formulation and upstream bioprocessing. Its product range includes solutions for a broad spectrum of biopharmaceutical applications, including CHO-based recombinant protein and antibody production, HEK293-based protein and viral vector production, and cell and gene therapy. The company has supported the commercial manufacturing of three projects for global multinational partners and has experience in supporting commercialized biopharmaceutical products through both FDA BLA and EMA submissions.
The global biopharmaceutical industry is experiencing significant growth, with more development pipelines moving from early research and process development to clinical and commercial manufacturing. This shift in the industry’s needs has created a growing demand for cell culture media that can support consistent performance during development while meeting the quality, scalability, traceability, and regulatory requirements of later-stage manufacturing. CelluPro’s EXCiPACT™ certification and its established cGMP-compliant quality system position it as a key player in this evolving landscape.
As the industry continues to diversify its process development and manufacturing needs, CelluPro is expanding its manufacturing and international supply capabilities. This expansion aims to provide biopharmaceutical manufacturers worldwide with an additional source of GMP-grade cell culture media and greater flexibility in global sourcing. With its robust quality management systems and extensive experience, CelluPro is well-positioned to meet the increasing demands of the biopharmaceutical industry.