Intended for Use in Pharma Mfg. Requiring ICH-Q7,
Excipient Grade Quality & Regulatory Compliance
D-Galactose, plant derived is intended for use upstream and downstream in biological drug manufacturing processes. For this purpose BioSpectra has categorized our product as an excipient though one of the primary functions is to be used as a nutrient in mammalian cell culture media. Given the sensitivity of these cells in regard to growth, BioSpectra’s D-Galactose is manufactured to meet high purity specifications and low bioburden and endotoxin demands.