Dublin, Ireland – September 3rd, 2015 – Aalto Bio Reagents, the largest provider of raw materials and controls to the in-vitro diagnostics industry and to research laboratories, today announced that the European Directorate for the Quality of Medicines and Healthcare (EDQM) is now recommending the use of their Rubella virus antigen in Fc function tests of injectable immunoglobulin.
Aalto Bio’s Rubella antigen (Aalto AW 6088) is purified and concentrated and is used in the Fc function tests of the company’s client IVIG products. Intravenous immunoglobulin (IVIG) is a sterile, purified Immunoglobulin G (IgG) manufactured from pooled human plasma and is used to treat immune deficiency.
Fig. 1 Schematic representation of IgG molecule.
In order to minimize possible adverse reactions, the functional integrity of IgG must be unaffected by methods of preparation and storage conditions. Numerous biologically relevant functions of IgG rely on the integrity of Fc fragments and so manufacturers are obliged to prove that Fc-mediated functions are maintained in their IVIG preparations.
“The European pharmacopoeia's monograph proposes a Rubella antigen-based test for Fc function of immunoglobulins. The EDQM has recommended Aalto Bio Reagent’s purified and concentrated Rubella virus antigen (Aalto code AW 6088) for this application. We are very pleased to now have over 15 pharmaceutical customers using our Rubella antigen in the Fc function test of their IVIG products,” said Philip Noone, CEO, Aalto Bio Reagents
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About Aalto Bio Reagents
Founded in 1978, Aalto Bio Reagents is a leading provider of raw materials to the in-vitro diagnostics industry and to research laboratories globally. We serve the largest multinational companies in our industry with a broad range of purified human proteins; monoclonal and polyclonal antibodies; fungal, parasitic, bacterial and viral antigens; and disease state plasma for in-vitro diagnostic application.
Since the company's inception, we have built strong working relationships with our clients who trust us to provide them with the highest quality raw materials to meet the exacting standards of their own product development requirements. Headquartered in Dublin, Ireland, the company is rapidly expanding both its product portfolio and customer base. For further information please visit http://www.aaltobioreagents.com