Cohn Fraction V Paste
Cohn Fraction V Paste and Fraction V Paste are created in the last step of both the Cohn Fractionation Process and in alternative fractionation processes. Fraction V paste is then further manufacturing into Albumin. The Fraction IV Paste that Seraplex supplies may be from a plasma fractionation company either in the United States or abroad, depending on the lot.
Through our relationships with biopharmaceutical manufacturers, Seraplex is able to source high quality lots of Cohn Fraction IV Paste.
Fraction V Paste from Cohn Fraction V cold ethanol plasma fractionation
Product # PS520
- Made from plasma of US origin collected from qualified human whole blood or source plasma donors at Blood Establishments with a current valid FDA Registration Certificate, collected according to FDA guidelines.
- Paste material manufactured according to documented procedures and GMP guidelines.
- Labeling
- Each paste unit will be labeled with product description and batch lot number.
- Appearance
- Yellow to brown in color, free of particulate matter.
- The individual plastic bag contents homogeneous in color and consistency with no unusual odor other than ethanol.
- Included with each shipment:
- Signed Certificate of Compliance with the following information:
- Certification of testing:
- Each donor unit used in the production of the paste has been tested by an FDA licensed laboratory with FDA licensed test kits.
- Test results Negative or Non-Reactive for HBsAg, anti-HBc, anti-HIV 1/2, anti-HTLV I/II,
anti-HCV, and Syphilis, HIV -1 RNA and HCV RNA. Results for other viral tests if performed such as HBV NAT, West Nile Virus and Chagas (T. cruzi) Negative or Non-Reactive. - In addition, the plasma may be tested by PCR for HAV, HBV, HCV, HIV and Parvo B-19.
- Certification of Storage Temperature: The paste has been stored at -20 C or below.
- Certificate of Analysis: Analysis of paste: Batch number, pH, total protein, albumin and globulin levels, weight of the paste batch supplied.
- Packaging
- Plastic bags packed in boxes with insulation material and dry ice
- Shipping
- Depends on customer specification.
- Transported to storage facility or final destination by freezer truck.
- Can be air-freighted in containers with dry ice.
- Next Day Delivery by Federal Express with dry ice
- Order Lead Time
- Depends on required quantity. Contracts and Standing Orders available.
Seraplex can assist companies interested in buying Cohn Fraction V Paste. Please contact us today to learn more information on how Seraplex can meet your Cohn Fraction V Paste needs. Send us an inquiry at info@seraplex.com or call (626) 792-9945.