#China #Yantai #GMP Certification #EXCiPACT #CelluPro

CelluPro Achieves Prestigious EXCiPACT™ Certification

In a significant milestone for the biotechnology industry, CelluPro has been awarded the EXCiPACT™ GMP Certification for its manufacturing of serum-free cell culture media. This notable accomplishment positions CelluPro as the first cell culture media supplier from China to receive this esteemed certification.

EXCiPACT™ is a globally recognized certification scheme aimed at pharmaceutical auxiliary materials, establishing rigorous Good Manufacturing Practice (GMP) requirements for products utilized in the biopharmaceutical manufacturing process. This certification serves as an impartial framework to evaluate key aspects such as quality management systems, manufacturing controls, traceability, and overall supply chain practices, setting a universal benchmark for quality management in cell culture media production.

With this certification, CelluPro reinforces its commitment to maintaining high standards in its established cGMP-compliant quality system—backed by additional certifications including ISO 9001, ISO 13485, ISO 14001, ISO 45001, and ISO 22301. These certifications collectively emphasize the company's dedication to quality management, environmental sustainability, occupational health and safety, and ensuring business continuity.

As the demand for biopharmaceutical innovations escalates, progress in development pipelines is transitioning from initial research and process development into clinical and commercial manufacturing. Consequently, this heightens the need for cell culture media that support consistent performance throughout these stages while adhering to quality, scalability, traceability, and regulatory demands associated with later-stage manufacturing.

Leveraging over ten years of expertise in the formulation of cell culture media and upstream bioprocessing, CelluPro serves a wide range of biopharmaceutical applications and cell culture procedures. The company's manufacturing framework ensures the production of cell culture media that encompasses all phases from process development to clinical and commercial manufacturing. Its offerings include a variety of applications such as CHO-based recombinant protein and antibody production, HEK293-based protein and viral vector generation, along with cell and gene therapy solutions.

Furthermore, CelluPro has previously supported three commercial manufacturing projects with various global multinational partners, demonstrating its capability to handle commercialized biopharmaceutical products successfully, as evident in submissions to the FDA Biological License Application (BLA) and the European Medicines Agency (EMA).

In response to the diverse and evolving needs of the global biopharmaceutical landscape, CelluPro is actively expanding its manufacturing and supply capabilities with the aim of supplying GMP-grade cell culture media to biopharmaceutical manufacturers worldwide. This expansion will provide greater flexibility in sourcing globally, thus bolstering the overall capabilities of the biomanufacturing sector.

To explore more about CelluPro and its GMP-grade solutions for cell culture media, visit www.cellupro.com.