Lot-to-lot consistent raw materials of highest quality is crucial in biopharmaceutical manufacturing. We supply a range of high quality amino acids and free-flowing, lot-to-lot consistent inorganic salts for use in the pharmaceutical and diagnostic industries, etc. The raw materials are manufactured in accordance with the Good Manufacturing Practices (GMP) guidelines and meet or exceed multi-compendial requirements.
We offer a wide range of high purity chemical inorganic salts with guaranteed lot-to-lot consistency for use in biopharmaceutical production. The lot-to-lot consistency of trace elements is critical to cell growth, and impurities can cease or impact therapeutical attributes.
The chemical salts are excellent for upstream and downstream processes and applications include use as pH buffers for fermentation, as process intermediates, and in cell culture media and protein synthesis. For upstream processes, salts such as copper, iron, magnesium, manganese and zinc salt deliver essential nutrients for cell cultures, bacteria and yeast. Our range of salts are fully traceable from raw material to final packaging. Furthermore, the salts are consistently pure with exceptionally low levels of elemental impurities.
Our range of inorganic salts for biopharma also includes a “Pharma Pure” line which, besides being high purity and multi-compendial, also is low in endotoxin. This low endotoxin-line is ideal for both upstream and downstream processes. Endotoxin is a toxin bound to the bacterial cell wall, which consist of lipopolysaccharides and lipoprotein. For use in finished pharmaceutical products, manufacturers are required to follow established good manufacturing practices, since the Pharma Pure products are low in endotoxins but not guaranteed free from the toxin.
Please contact contact us for more information about specific products and for our full product list of salts for upstream and downstrean processes.
Our line of ultra high purity chemical salts has exceptionally low levels of impurities. We guarantee lot-lo-lot consistency of trace elements which is critical to cell growth, since changes in levels of elemental impurities can cease growth. Furthermore, changes can also impact therapeutic attributes.
Heavy metal 1 ppm maximum
Arsenic (As) 0.1 ppm maximum
Lead (Pb) 0.1 ppm maximum
Mercury (Hg) 1 ppm maximum
Lene Aarøe Nissen
Head of Nordic Sales
+45 22 70 10 02