Biopharmaceutique

Bio Pharma Grade L-Cystine DiHydrochloride LCYS-4250 is suitable for use as a process chemical. It is manufactured in accordance with the IPEC-PQG Joint Good Manufacturing Practice Guide. This grade of L-Cystine DiHydrochloride is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.

Tromethamine (Tris), is commonly used as a buffer and excipient in biological applications downstream in the manufacture of drug products. Tris is considered a “Good’s” buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water.

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.

High Purity Sodium Hydroxide 10N solution is intended for use in critical pharmaceutical processes, both upstream and downstream. This product is manufactured utilizing a proprietary, fully dedicated, validated GMP system that utilizes multiple manufacturing and purification steps to achieve high purity results without the use of pellets.