Ex Vivo Therapeutics

Serum-free Media

Production

• Produced under Good Manufacturing Practice (GMP)

Formulation and Composition

• Available in 500 ml bottles and 500 ml bags. Customized batches on request
• Both media provide a nutritionally complete and balanced environment for your cells
• Media are serum-free, contain human derived and/or human recombinant proteins
• The media do not contain antibiotics, growth factors and cytokines
• The media contain phenol-red as pH indicator

Release Controls

• Sterility (Ph.Eur.)
• Endotoxin (Ph.Eur.)
• Osmolality (Ph.Eur.)
• pH-value (Ph.Eur.)
• Mycoplasma (Ph.Eur.)
• Functionality ( Bioassay)
• Appearance and Colour

Documentation

• Data Sheet (for download)
• Certificate of Analysis (batch-specific)
• MSDS (on request)

Regulatory Support

• GMP-compliance audit (on request)
• FDA Drug Master File cross reference (on written request)
• Raw material documentation (on authority request, under terms of CDA)

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 +2 to +8 °C