Cohn Fraction I+III Paste
Cohn Fraction I+III Paste is collected from our plasma fractionation suppliers in the early stages of the fractionation process. Seraplex can source different sized lots, depending on our customers requests. Contact us today to see how Seraplex can meet your Cohn Fraction I+III needs.
The Cohn Fraction I+III Paste is 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 and / or a current valid Establishment License, collected according to FDA guidelines.
The paste material is manufactured according to documented procedures and GMP guidelines.
Each paste unit will be labeled with product description and batch lot number, and is yellow to brown in color, free of particulate matter.
- Fraction I+III Paste from Cohn Fraction cold ethanol plasma fractionation
Product # PS500 - 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 and / or a current valid Establishment License, 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 should be 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.
- Signed Certificate of Compliance with the following information:
- 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.
If you are interested in buying Cohn Fraction I+III for your manufacturing needs, please contact us at [email protected] or call (626) 792-9945.
Contact – Office Number
(626) 792-9945