Human Serum Albumin, Liquid
Seraplex has unique access to Human Serum Albumin (HSA) from our network of plasma fractionation companies.
Seraplex’ HSA can be used for in vitro diagnostic manufacturing.
Seraplex’ Human Serum Albumin (HSA) derivatives are available from therapeutic manufacturers as expired therapeutic grade product or product that is suitable for in vitro diagnostic manufacturing. The liquid HSA is supplied in 100 ml bottles of 20 0r 25% solution. A certificate of analysis which includes protein concentration and Albumin purity is accompanied with each HSA batch.
Human Albumin, Liquid (4.5% or 20% solution)
Product # PS981
- 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.
- Material manufactured according to documented procedures and GMP guidelines.
- Material may be out-dated or expired for therapeutic use.
- Labeling
- Product name, lot number, grams/volume, storage temperature
- Appearance
- Slightly yellow solution, free of particulate matter.
- Included with each shipment
- Signed Certificate of Compliance with the following information:
- Certification of testing:
- Each donor unit used in the production of the product 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 used for manufacture may be tested by PCR for HAV, HBV, HCV, HIV
and Parvo B-19.
- Certification of Storage Temperature
- The product has been stored at 2 – 8 C.
- Certificate of Analysis with the following information
- Manufacture date, Batch number, pH, total protein, albumin and globulin levels
- Packaging
- Plastic or glass bottles
- Shipping
- Depends on customer specification.
- Shipped refrigerated or at ambient temperature
- Order Lead Time
- Depends on required quantity. Contracts and Standing Orders available.
Seraplex can source Human Serum Albumin, Liquid for in vitro diagnostic manufacturers. Send your inquiry to info@seraplex.com or call (626) 792-9945.