Ex Vivo Therapeutics

GMP Cytokines

Production

• Produced in E.coli on the basis of Good Manufacturing Practice (GMP)
• (if possible) no usage of animal derived components

Formulation & Composition

• Lyophilized proteins from a solution of PBS
• Carrier-free, without stabilizers (i.e. HSA)
• Vial size: 50 µg

QC Release Controls

• Sterility (Eu.Pharm.)
• Endotoxin (Eu.Pharm.)
• Purity
• Identity
• Specific Activity
• Host-Cell DNA

Documentation

• Data Sheets, Handling Instructions (for download)
• Certificate of Analysis (batch-specific)
• Production overview (on request)
• MSDS (on request)

Regulatory Support

• Comprehensive QC documentation
• GMP-compliance audit (on request)
• FDA Drug Master File cross reference (on written request)

Shelf life, Transport & Storage

• Shelf life: 2 years from date of production, minimum 6 months from date of shipping
• Transport: at ambient temperature (stability validated)
• Storage: recommended at -20 to -80 °C