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New Human Immunoglobulin Reference Standards Available

Reference Standard
Biological reference preparation (BRP)
18 September 2017
Strasbourg, France

Following the adoption of new human immunoglobulin reference standards, existing sales restrictions have been lifted.  The following new standards are now available in the EDQM catalogue:

  • Human immunoglobulin (molecular size) BRP batch 2 (Y0000488)
  • Human immunoglobulin for Fc function BRP batch 1 (Y0001966)

The following reference standards will continue to be sold until the stocks are depleted:

  • Human immunoglobulin BRP (Fc Function and Molecular size) batch 2 (Y0001512)
  • Human immunoglobulin BRP (ACA and Molecular size) batch 1 (Y0001504)

Once the latter standard is exhausted, a human immunoglobulin for anticomplementary activity BRP batch will be available (catalogue reference to be attributed).

The concerned chapters of the European Pharmacopoeia have been revised to introduce the new nomenclature and will enter into force in January 2018.

The reference standards were established in a Biological Standardisation Programme study, the outcome of which will be published shortly in Pharmeuropa Bio & Scientific Notes.

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