#China #Yantai #GMP Certification #EXCiPACT #CelluPro

CelluPro Achieves EXCiPACT™ GMP Certification

In a significant development for the biopharmaceutical industry, CelluPro, a prominent biotechnology firm known for its serum-free cell culture media and bioprocess solutions, has recently been awarded the EXCiPACT™ GMP certification. This milestone not only marks CelluPro as the first Chinese provider of cell culture media to achieve this international certification but also underscores its commitment to maintaining high-quality standards in the manufacturing of pharmaceutical excipients.

What is EXCiPACT™?

The EXCiPACT™ certification system is globally recognized and focuses on the quality management of pharmaceutical excipients, which are essential materials used in biopharmaceutical production. The certification defines Good Manufacturing Practice (GMP) requirements necessary for materials utilized in the biomanufacturing sector. By receiving this certification, CelluPro has established an independent framework for evaluating essential criteria such as quality management, manufacturing controls, traceability, and adherence to supply chain practices.

Strengthening Quality Systems

CelluPro's newly acquired EXCiPACT™ certification enhances its established cGMP-compliant quality system. This system is further supported by various other certifications, including ISO 9001, ISO 13485, ISO 14001, ISO 45001, and ISO 22301. Collectively, these certifications affirm the company's dedication to quality management, environmental management, occupational health and safety, and business continuity. This confluence of standards provides CelluPro's partners in the biopharmaceutical field with confidence in the products and services they receive.

Meeting Growing Demand

As the global biopharmaceutical landscape rapidly evolves with increasing innovation and the transition of many development projects from early-stage research to clinical and commercial manufacturing, the demand for reliable and high-quality cell culture media is more pressing than ever. CelluPro recognizes this trend, noting that the need for cell culture media that deliver consistent performance while fulfilling quality standards, scalability, traceability, and regulatory requirements is growing.

With over ten years of experience in cell culture formulations and upstream bioprocessing, CelluPro has crafted products for a broad spectrum of biopharmaceutical applications and cell culture processes. Their production platform supports the entire lifecycle of cell culture media, from initial process development to clinical and commercial manufacturing. Specific applications include the production of recombinant proteins, antibodies based on CHO cells, HEK293-based protein and viral vector production, as well as cell and gene therapy applications.

Global Reach and Capacity Expansion

CelluPro has played a vital role in three major commercial production projects for multinational partners, showcasing its capabilities in supporting the commercialization of biopharmaceutical products through FDA Biologics License Applications (BLA) and EMA authorization processes. As the biopharmaceutical industry continues to diversify its demands for process development and manufacturing, CelluPro is strategically expanding its production and international supply capabilities. This expansion will facilitate an additional source of GMP-grade cell culture media for global biomanufacturers, ultimately offering greater flexibility in sourcing.

Furthermore, this growth not only reflects CelluPro's responsiveness to market demands but also highlights its ambition to become a key player in the global biopharmaceutical supply chain. As the company continues to innovate and refine its product offerings, it remains committed to fostering partnerships that embrace quality and sustainability in biomanufacturing.

To learn more about CelluPro’s commitment to certified GMP-grade cell culture media, visit CelluPro.