Ficoll-Paque Premium provides the same proven results as Ficoll-Paquep Plus with the added value of sterile manufacturing standards and ISO quality systems
GE Healthcare has announced the launch of Ficoll-Paque Premium.
Ficoll-Paque has been used for around 30 years to prepare human mononuclear cells from blood and marrow.
Ficoll-Paque Premium provides the same proven results as Ficoll-Paque Plus with the added value of sterile manufacturing standards and ISO quality systems.
"Compliance to GMP and quality standards is increasingly important to our customers using reagents such as Ficoll-Paque.
"The new Ficoll-Paque Premium provides our customers with the proven attributes of Ficoll-Paque Plus, but with the added assurance of stringent manufacturing process controls and adherence to quality systems to reduce risk", said Nigel Darby, VP of research and development, protein separations at GE Healthcare.
"We're proud to offer this latest value product to our cell processing platform".
Ficoll-Paque Premium is based on Ficoll-Paque Plus, which has a proven track record as a sterile density medium for the isolation of high yields of mononuclear cells from bone marrow, peripheral blood, and umbilical cord blood.
Ficoll-Paque Premium differs from Ficoll-Paque Plus in that it is manufactured in a strictly controlled environment compliant with ISO and EC Guide to GMP (good manufacturing practice), annex 1, Manufacture of Sterile Medicinal Products, and in accordance with the recommendations of the United States Pharmacopeia (section 1043) for the manufacture of cell therapy products.
ISO and GMP compliance requires stringency in validation and documentation of manufacturing procedures, and adherence to strict quality systems.
This secures the high product quality and safety of Ficoll-Paque Premium, with product sterility, low endotoxin levels, and reproducible performance.
All other aspects of the Ficoll Paque Premium are the same as for Ficoll-Paque Plus.
