#China #Yantai #Biomanufacturing #EXCiPACT #CelluPro

CelluPro Achieves EXCiPACT™ Certification

On September 7, 2026, CelluPro, a leading biotechnology firm based in Yantai, China, announced a significant milestone in its operational capabilities by securing the EXCiPACT™ GMP certification for its cell culture media. This achievement marks CelluPro as the first Chinese manufacturer to obtain such recognition, illustrating its commitment to high standards in the ever-evolving field of biomanufacturing.

Understanding EXCiPACT™ Certification

The EXCiPACT™ certification is a globally recognized program dedicated to pharmaceutical excipients, which governs the Good Manufacturing Practices (GMP) necessary for materials used in the production of biopharmaceutical products. This independent certification serves as a benchmark to assess quality management, manufacturing controls, traceability, and supply chain practices. By receiving the EXCiPACT™ certification, CelluPro affirms its dedication to the highest quality manufacturing standards necessary in today’s competitive and regulatory-intensive environment.

Strengthening Quality Systems

This certification enhances CelluPro’s already established quality system, which adheres to current Good Manufacturing Practices (cGMP). The company is also certified with multiple international standards, including ISO 9001, ISO 13485, ISO 14001, ISO 45001, and ISO 22301, underscoring its comprehensive approach to quality, environmental management, occupational health and safety, and business continuity. Collectively, these certifications highlight CelluPro’s unwavering focus on quality assurance and sustainable practices to support its global biopharmaceutical partners.

Meeting Growing Demand

As biopharmaceutical innovation continues to gain momentum, an increasing number of projects are advancing from initial research phases to clinical and commercial manufacturing stages. Consequently, the demand for reliable cell culture media has soared, necessitating products that maintain consistent performance during development while simultaneously meeting evolving regulatory and quality requirements. As specialized applications for cell culture media grow, so too does the need for suppliers capable of delivering quality assurance and scalability.

With over a decade of expertise in formulating cell culture media and bioprocessing, CelluPro has developed a range of products applicable to various biopharmaceutical processes. The company’s advanced manufacturing platform facilitates the production of cell culture media, from process development to clinical and commercial manufacturing. Notably, this includes applications such as producing recombinant proteins and antibodies using CHO cells, generating proteins and viral vectors derived from HEK293 cells, and contributing to cell and gene therapies.

Collaboration with Global Partners

CelluPro has successfully supported three commercial manufacturing projects in collaboration with multinational partners. The firm has significant experience in aiding biopharmaceutical products that require market license applications (BLAs) both for the U.S. FDA and the European Medicines Agency (EMA). This extensive experience positions CelluPro as a trusted supplier in the biopharmaceutical sector, capable of facilitating product launches and compliance with regulatory requirements.

Future Directions

In response to the biopharmaceutical industry's continuously diversifying development and manufacturing needs, CelluPro is enhancing its production and international supply capabilities. This strategic move aims to provide biopharmaceutical manufacturers worldwide with an alternative source of GMP-compliant cell culture media, enhancing flexibility in global supply chains. As the industry evolves, CelluPro remains committed to supporting its partners with quality products that streamline the path to successful biopharmaceutical development.

For more information about CelluPro and its GMP-compliant cell culture media solutions, visit www.cellupro.com.

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Contact Information:
CelluPro, Ltd.
Email: [email protected]
Phone: +86 535-3573434