Great HSA from a great new Team: Octapharma and SeraCare

SeraCare, the premier supplier of blood based products for the in vitro diagnostic market, is pleased to announce collaboration with Octapharma, the largest, privately owned plasma products manufacturer in the world, to therapeutic grade human serum albumin (HSA).

A sampling of some of the many applications in which human serum albumin (HSA) is used are:

• Cell culture media or supplement for biological growths and expression
• Diluent / stabilizer for in vitro diagnostic tests
• Excipient for pharmaceuticals

SeraCare offers a consistently reliable source of high quality HSA available from stock.

To go along with an excellent product, SeraCare offers the excellent support that you've come to expect. We get answers to your questions fast with SeraCare's responsive technical staff, which includes regulatory support from our team with years of experience. Supplemented by the attention, experience and training of the professionals at Octapharma we offer an unbeatable combination.

SeraCare's therapeutic grade HSA is manufactured with safety top-of-mind with your safety and product quality assured. Our therapeutic grade HSA is United States Pharmacopeia (USP) and European Pharmacopeia (EP) listed.

And for just added convenience:

New and now available:
20% HSA solution approved by the US FDA October 2007.

SeraCare also offers 20% HSA to compliment the previously available 25% HSA solution.

Quality and Safety

A comprehensive quality control program includes testing for visual control, specificity (Ouchterlony), protein composition (Immuno & CAF - electrophoresis), purity, pH, polymers & aggregates, heme content, PKA, electrolytes, stabilizers, osmolality, sterility, viral markers, and stability. 20% HSA is <0.04 mcg/ml and =25% HSA is < 0.05 mcg/ml. The product composition is > 96% human serum albumin. It may be stored for three years after the manufacture date at room temperature (+2°C to 25°C/ 36°F to 77°F). Internal stabilities studies indicate good stability for up to five years.

Our therapeutic grade HSA is designed for excellent reduction of enveloped and non-enveloped viruses. Each unit of plasma is screened for HIV-1 / HIV-2, HBV, HCV, WNV, ALT, and Parvovirus B19. Plasma pools are screened for HIV-1 / HIV-2, HBV and HCV (see our product inserts). Octapharma has reported no product recalls since the introduction of this product since it was introduced in 1992 and in the United States in 2006.

SeraCare is pleased to offer human serum albumin (HSA) in a variety of grades, concentrations and sizes:

Validation information

Therapeutic grade HSA from SeraCare is approved for use only in non-in vivo applications. It is prepared as if for therapeutic use and is distributed as a controlled substance.

Diagnostic Grade HSA

SeraCare also offers a full line of diagnostic grade HSA. Albumin and globulin powders are soluble, off-white, diagnostic grade of ultra-high purity, fractionated according to Cohn Cold Alcohol techniques from fully traceable, documented plasma from U.S. sources. All units of plasma used to manufacture SeraCare's Albumin Powders and Solutions were collected exclusively in the U.S., and have been tested and found to be non-reactive for HBsAg, Anti-HCV, Anti-HIV-1 and Anti-HIV-2.

Performance

• > 98% Protein with Albumin Purity levels > 97%
• Virally inactivated, low endotoxin and low protease levels
• Ideal choice for sensitive diagnostic assays and applications
• Extensively tested for a full panel of safety and analytical data
• Albumin levels typically very high
• Gamma globulins virtually undetectable by standard methods

Product Information

• 20% Solution Package Insert
• 25% Solution Package Insert
• HSA sell sheet

For more information or to place an order, contact your SeraCare representative or SeraCare customer service.

US Toll Free 1.800.676.1881
Tel. 508.580.1900
Fax 508.580.2202
info@seracare.com