Planning and design of stem cell product development route based on QbD concept

Stem cell isolation, identification, bank construction, assay and preservation

Industrialization-oriented stem cell process development and scale-up

Quality control of stem cell products and strategy consultation

Analytical method development and quality study meeting the requirements for external application

Preparation of pharmaceutical study and IND application dossier of stem cell products

Production of clinical trial samples and large-scale commercial production

WuXi ATU cell therapy CTDMO platform is planned and designed based on the QbD concept. With BSL-2 level biosafety, independent air-conditioning full exhaust system and disposable and fully enclosed flexible production process, it effectively prevents contamination and cross contamination while reducing the cost of large-scale production.

Static culture, stirring culture and swing culture and other flexible cell amplification methods meet the needs of customers at different scales

A complete quality management system with complete production traceability and compliance provides customers with more rapid, convenient, safe and effective immune cell therapy products

Interstitial Stem Cell Production Process

BSL-2 level biosafety, independent air conditioning system, full exhaust clean background environment

Fully enclosed disposable sterile production process, separate personnel flow, sample flow and material flow, one-way flow design, to minimize contamination and cross contamination

Modular design, flexible arrangement of production, to meet the needs of different scales of production full process traceability, safe and reliable

Human genetic material management system meeting the regulatory requirements