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Strictly Confidentiality
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Quality System
• Certificated by TÜV NORD as per ISO9001:2015
• Facilities operated under full GMP guidance
• Materials conform to ChP/EP/USP/ACS/BP/JP or company standards
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Capacities
• Dry Powder: 1-2000kg/lot
• Liquid: 1-2000L/lot
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Fully Informatized and Automated
• Reliable and traceable data recorded by the medium production process with information system
• Small and uniform particle size of dry powder
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Customized QC Service
• Appearance
• Solubility
• pH
• Endotoxin
• Osmolarity
• Bioburden
• Sterility
• Qualification & Quantification of Specified Components
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Consistent Quality
• Intra-lot & inter-lot RSD＜5% in cell performance assay
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Short Lead Time & Safe Supply
• Facilities: ≈8000m2 cell culture medium manufacturing facilities are built at 2 sites
• Supply chain: In addition to the major suppliers, OPM has 2 or more qualified suppliers for each and every raw and packaging material