#China #Yantai #Biomanufacturing #GMP Certification #CelluPro

CelluPro Achieves EXCiPACT™ Certification

In a significant milestone for the biotechnology sector, CelluPro has become the first Chinese provider of cell culture media to obtain the EXCiPACT™ GMP certification. This certification is a testament to their commitment to adhering to rigorous Good Manufacturing Practices (GMP) in the field of biomanufacturing. The EXCiPACT™ scheme is recognized internationally for establishing standards related to quality management, manufacturing controls, traceability, and supply chain practices, particularly applicable to pharmaceutical excipients used in biopharmaceutical manufacturing.

With this certification, CelluPro fortifies its quality management system, which already conforms to various ISO certification standards, including ISO 9001 for quality management, ISO 13485 for medical devices, ISO 14001 for environmental management, ISO 45001 for occupational health and safety, and ISO 22301 for business continuity management. The integration of these certifications ensures high standards of quality and operational excellence, supporting CelluPro's mission to deliver quality products to its biopharmaceutical partners globally.

The biotechnology landscape is rapidly evolving, with a significant rise in projects transitioning from initial research and development stages to clinical and commercial manufacturing. As a result, the demand for high-quality cell culture media that provides consistent performance throughout the development process is surging. CelluPro aims to meet these burgeoning needs by providing cell culture media that adhere to stringent quality requirements, scalability, traceability, and compliance with regulations required in later-stage manufacturing.

CelluPro boasts over a decade of experience in the design of cell culture media and bioprocessing. Their extensive range of products caters to diverse biopharmaceutical applications, including the production of recombinant proteins and monoclonal antibodies using CHO cells, vector production through HEK293 cells, and therapies involving cell and gene processing. Their manufacturing capability is adept at supporting clinical and commercial requirements, ensuring that they keep pace with the dynamic demands of biomanufacturing.

Moreover, CelluPro has demonstrated its value to global multinational corporations by successfully supporting three commercial manufacturing projects and assisting with filed products under FDA BLA and EMA regulations. This experience positions CelluPro uniquely to offer extensive support to commercialized biopharmaceutical products, reinforcing its reputation in the industry.

As the bio-pharmaceutical industry continues diversifying its process development and manufacturing requirements, CelluPro is set to expand its international manufacturing and supply capabilities. This development will not only provide additional sources of GMP certified cell culture media but will also enhance flexibility in global sourcing for biomanufacturers around the globe.

In conclusion, CelluPro’s achievement of the EXCiPACT™ certification signifies a major leap forward in their capabilities and reaffirms their commitment to quality and compliance. As the demand for high-quality biomanufacturing solutions rises, CelluPro is poised to be a pivotal player in ensuring these needs are met efficiently and reliably.

For more information about CelluPro and their GMP-certified cell culture media solutions, visit CelluPro's official website.