Yantai, China — September 7, 2026
CelluPro, Ltd. announced that it has received EXCiPACT™ GMP Certification for Pharmaceutical Auxiliary Materials (PAMs), strengthening its position as a supplier of GMP-grade cell culture media for the global biopharmaceutical manufacturing industry. The certification makes CelluPro the first Chinese cell culture media supplier to receive EXCiPACT™ certification, according to the company. EXCiPACT is an internationally recognized certification scheme that establishes GMP requirements for pharmaceutical auxiliary materials used in biopharmaceutical manufacturing. For CelluPro, the certification provides an independent framework covering quality management, manufacturing controls, traceability and supply-chain practices associated with its cell culture media production. The development is particularly relevant to biopharmaceutical manufacturers seeking qualified suppliers capable of supporting increasingly demanding production environments. By adding EXCiPACT certification to its existing quality infrastructure, CelluPro is strengthening its manufacturing credentials and expanding its ability to serve customers requiring consistent, traceable and GMP-aligned raw and auxiliary materials for bioprocessing applications.
EXCiPACT Certification Expands CelluPro Quality Framework
The new certification builds on CelluPro’s established cGMP-compliant quality system and broader certification portfolio. The company said its quality and operational framework is also supported by ISO 9001, ISO 13485, ISO 14001, ISO 45001 and ISO 22301 certifications, covering areas including quality management, medical-device quality systems, environmental management, occupational health and safety, and business continuity. The addition of EXCiPACT certification provides further independent recognition of CelluPro’s manufacturing and quality-management practices for pharmaceutical auxiliary materials. For customers using cell culture media in biopharmaceutical processes, supplier qualification is an important part of maintaining reliable manufacturing operations, particularly as programs progress from development into clinical and commercial production. CelluPro’s expanded certification framework therefore strengthens its ability to demonstrate controlled manufacturing and supply-chain traceability to global biopharmaceutical customers. The certification also supports the company’s broader strategy of expanding international supply capabilities and providing manufacturers with an additional qualified source for cell culture media.
Manufacturing Platform Supports Advanced Bioprocessing Applications
CelluPro has more than 10 years of experience in cell culture media formulation and upstream bioprocessing, with manufacturing capabilities designed to support applications from process development through clinical and commercial manufacturing. The company develops serum-free cell culture media for multiple biopharmaceutical production platforms, including CHO-based recombinant protein and antibody manufacturing and HEK293-based protein and viral-vector production. Its solutions also support cell and gene therapy applications, placing its manufacturing platform within several areas of advanced biopharmaceutical development. Cell culture media are critical inputs in upstream manufacturing because they support the growth and productivity of production cells used to generate biological products. As biopharmaceutical programs move toward later-stage development and commercialization, manufacturers increasingly require suppliers that can provide reliable production, consistent quality and appropriate documentation. CelluPro said its manufacturing platform has supported three commercial manufacturing projects for global multinational partners, while its experience includes supporting commercialized biopharmaceutical products through FDA BLA and EMA submissions.
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CelluPro Targets Global Biomanufacturing Supply Expansion
The EXCiPACT certification comes as CelluPro expands its global manufacturing and supply capabilities for biopharmaceutical customers. The company is positioning its GMP-grade cell culture media platform as an additional sourcing option for manufacturers seeking greater flexibility and resilience within their global supply chains. The certification can strengthen CelluPro’s ability to engage with customers whose supplier qualification processes require internationally recognized quality standards for pharmaceutical auxiliary materials. Its manufacturing focus spans development, clinical manufacturing and commercial production, allowing the company to target customers across multiple stages of the biopharmaceutical lifecycle. The combination of EXCiPACT GMP certification, cGMP-compliant manufacturing and international quality certifications provides CelluPro with a stronger foundation for expanding its presence in global biomanufacturing. The company said it will continue expanding its manufacturing and international supply capabilities as biopharmaceutical manufacturers face increasingly diverse process-development and production requirements. The latest certification therefore represents a significant manufacturing and quality milestone for CelluPro and strengthens its positioning within the global cell culture media supply market.
Source: CelluPro, press release
