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CelluPro Receives EXCiPACT™ Certification for GMP-grade Cell Culture Media Manufacturing, Strengthening Global Biomanufacturing Supply Capabilities

CelluPro, Ltd.

YANTAI, China, Sept. 7, 2026 /PRNewswire/ -- CelluPro, a biotechnology company specializing in serum-free cell culture media and bioprocess solutions, has achieved EXCiPACT™ GMP Certification for Pharmaceutical Auxiliary Materials (PAMs), becoming the first Chinese cell culture media supplier to receive EXCiPACT™ certification.

EXCiPACT™ is an internationally recognized certification scheme for pharmaceutical auxiliary materials, establishing GMP requirements for materials used in biopharmaceutical manufacturing. The certification provides an independent framework for assessing quality management, manufacturing controls, traceability, and supply chain practices. For cell culture media suppliers, EXCiPACT™ certification represents an internationally recognized standard for GMP manufacturing and quality management.

The certification further strengthens CelluPro's established cGMP-compliant quality system, which is also supported by ISO 9001, ISO 13485, ISO 14001, ISO 45001, and ISO 22301 certifications, covering quality management, environmental management, occupational health and safety, and business continuity. Together, these certifications support CelluPro's quality and sustainability practices in serving biopharmaceutical partners worldwide.

As biopharmaceutical innovation continues to expand, more development pipelines are progressing from early research and process development toward clinical and commercial manufacturing. As a result, cell culture media are being used across an increasingly broad range of development and manufacturing activities, creating growing demand for media that can support consistent performance during development while meeting the quality, scalability, traceability, and regulatory requirements of later-stage manufacturing.

With more than a decade of experience in cell culture media formulation and upstream bioprocessing, CelluPro develops products for a broad range of biopharmaceutical applications and cell culture processes. Its manufacturing platform supports cell culture media production from process development through clinical and commercial manufacturing, with applications including CHO-based recombinant protein and antibody production, HEK293-based protein and viral vector production, and cell and gene therapy.

CelluPro has supported three commercial manufacturing projects for global MNC partners and has experience supporting commercialized biopharmaceutical products through both FDA BLA and EMA submissions.

As the global biopharmaceutical industry continues to diversify its process development and manufacturing needs, CelluPro is expanding its manufacturing and international supply capabilities to provide biopharmaceutical manufacturers worldwide with an additional source of GMP-grade cell culture media and greater flexibility in global sourcing.

Learn more about CelluPro and its GMP-grade cell culture media solutions: www.cellupro.com

CelluPro, Ltd.
info@cellupro.com
+86 535-3573434

提供:PR Newswire
発信企業・団体
CelluPro, Ltd.
業種カテゴリ
医療・健康・介護
発表日時
2026-09-07 15:00 (JST) 原文: 2026-09-07 14:00 (+08:00)
原文
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