CelluPro Receives EXCiPACT™ Certification for GMP-grade Cell Culture Media Manufacturing

CelluPro is now certified to the EXCiPACT™ GMP Standard for Pharmaceutical Auxiliary Materials (PAMs). CelluPro is also the first Chinese cell culture media supplier to receive the  EXCiPACT certification.

EXCiPACT™ is an internationally recognized GMP guideline specifically developed for materials such as cell culture media that play a critical role in biopharmaceutical manufacturing.

The certification validates CelluPro's quality management system, manufacturing operations, and supply chain controls for the production of GMP-grade cell culture media, demonstrating the company's ability to provide reliable, consistent, and globally compliant solutions for biopharmaceutical manufacturing.

A Commitment to Quality Beyond Compliance

At CelluPro, quality is the foundation of everything we do. CelluPro has established a comprehensive quality management system supported by internationally recognized certifications, including:

• EXCiPACT™ Certification

• ISO 9001 Quality Management System

• ISO 13485 Medical Device Quality Management System

• ISO 14001 Environmental Management System

• ISO 45001 Occupational Health and Safety Management System

• ISO 22301 Business Continuity Management System

Together, these certificates witness CelluPro’s product quality, supply chain resilience, and operational excellence throughout the entire product life cycle.

Advanced Manufacturing for GMP-grade Cell Culture Media

CelluPro's state-of-the-art manufacturing facilities are specifically designed to support robust, scalable, and regulatory-compliant bioprocessing from early development to commercial manufacturing.

Supported by advanced manufacturing technologies, digitalized quality management systems, and stringent raw material controls, CelluPro delivers GMP-grade cell culture media with exceptional consistency and reliability.

• Consistent Performance at Scale

CelluPro GMP-grade media ensure robust cell growth, high viability, and reproducible productivity with strong lot-to-lot consistency.

• Reliable Product Quality

Formulated under controlled manufacturing systems, supporting stable critical quality attributes (CQAs), including glycosylation, purity, and structural consistency.

• Scalable and Robust Manufacturing

Designed for seamless transition from process development to pilot and large-scale commercial bioreactors with minimized process variability.

• Accelerated Process Development

Helps reduce optimization cycles and improves process efficiency, supporting faster progression from development to clinical manufacturing.

• Regulatory-Ready Quality System

Manufactured under a GMP-compliant quality system with full traceability and documentation to support IND/BLA submissions and global regulatory expectations.

Delivering Confidence for Global Biomanufacturing

CelluPro's manufacturing platform integrates advanced powder processing technologies, comprehensive analytical capabilities, and digitalized manufacturing systems to ensure consistent delivery of high-quality products.

Today, CelluPro supports more than 75 biopharmaceutical programs worldwide, including 3 commercial manufacturing projects, helping customers accelerate the development and commercialization of innovative biologics.