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Extended range of GMP manufactured Ficoll-Paque PREMIUM products
The Ficoll-Paque™ PREMIUM product range is now extended to include Ficoll-Paque PREMIUM 1.073 and Ficoll-Paque PREMIUM 1.084:
- Ficoll-Paque PREMIUM 1.073 is intended for isolating lower-density human mononuclear cells such as mesenchymal stromal cells, or monocytes.
- Ficoll-Paque PREMIUM 1.084 is intended for isolating higher-density human mononuclear cells and for separating blood cells from mice or rats.
 Ficoll-Paque PREMIUM products are a range of sterile, ready-to-use density gradient media* for the preparation of mononuclear cells in clinical applications. All Ficoll-Paque PREMIUM products are based on Ficoll-Paque PLUS (see Ficoll-Paque™ PLUS), which has been used for more than 30 yr as a sterile density reagent for the isolation of high yields of mononuclear cells from bone marrow, peripheral blood, and cord blood.
Features of Ficoll-Paque PREMIUM products are:
- Manufactured in a strictly controlled environment compliant with ISO 13485:2003 and in accordance with Annex 1 of the EC Guide to Good Manufacturing Practice (GMP) “Manufacture of Sterile Medicinal Products” .
- Manufactured according to the recommendations of the United States Pharmacopeia, Chapter <1043>, for the manufacture of cell therapy products.
- Low levels of endotoxin (< 0.12 EU/ml) secured and tested.
- Sterile and ready-to-use reagents easily incorporated in to existing protocols.
A Regulatory Support File (RSF) is available for Ficoll-Paque PREMIUM, for information on how to order an RSF, please visit our Regulatory Support Web site at www.gehealthcare.com/rsf
*For in vitro use only
Read more in the updated Ficoll Paque PREMIUM products Data file
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