Page 28 - PCC02

The case of growth factors
• To quote
Alan Handyside:
• ”in vivo they see a galaxy of growth factors..”
• What about in vitro, what’s worst?
– No added growth factors?
– One or two in super‐physiological‐concentrations?
Production Quality Control
• Physiochemical properties
– pH, osmolality
– sterility/bioburden
– viscosity
– hSA concentration
– Antibiotics concentration
• Standardized tests
• Biological assays
– Endotoxins
– Mouse embryo assay
– Sperm survival assay
• Test method may vary between manufacturers
Cost of QC is substantial compared to cost of ingredients
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