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CSL Bioplasma Report

Ongoing demand for our plasma fractionation services together with growth in our Asian markets for commercial products manufactured by CSL Behring has delivered a 32% increase in CSL Bioplasma sales this year to $334 million.

Our plasma fractionation facility in Melbourne has continued to provide plasma fractionation services under contracts with Australia, New Zealand, Hong Kong, Malaysia, Singapore, and Taiwan. Again this year, Australia and New Zealand increased volumes of plasma for fractionation.

Our continuing robust operation has been ensured by the equipment upgrades and the process automation and control system that we introduced last year. The ongoing success of our manufacturing operations is underpinned by close attention to continuous improvement and to operational excellence. Expansion is planned to meet future needs in Australia and for our international toll fractionation customers.

Growth in Asia has been underpinned by increased sales of albumin in China. As the leading supplier of plasma fractionation services and products in the Asia Pacific, we have worked with our distributors to expand the regional sales of products surplus to the demands of our contract fractionation customers.

We completed Phase III clinical trials of Intragam® 10 NF, our high-yielding, chromatographically purified 10% intravenous immunoglobulin for idiopathic thrombocytopenic purpura and primary immune deficiency. A dossier for this product has been submitted to the Therapeutic Goods Administration (TGA) seeking registration. In Australia and New Zealand, recruitment has progressed for the Phase III trial of our high-yielding, chromatographically purified 16% immunoglobulin for subcutaneous use.

During the year, both the TGA and the New Zealand Medicines and Medical Devices Safety Authority (MedSafe) approved registration of our Biostate® (Factor VIII/von Willebrand Factor) for the treatment of von Willebrand disease.

Grace O’Brien

CSL Bioplasma scientist, Grace O’Brien, uses gel electrophoresis to characterise the protein profile of a plasma product. R&D work at CSL Bioplasma has a significant focus on enhancing manufacturing processes for our thrombosis and haemostasis products.