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European Biopharmaceutical Review

Human Impact

EBR: Can you give an overview of your company’s work on human proteins?

Stefan Wietek: Founded in 1983, Octapharma is now the world’s largest privately owned plasma manufacturer. It markets human plasma-derived proteins, the first of which was Octavi, a purified factor VIII that is required for blood clotting. The innovative solvent/ detergent (SD) treatment process we introduced has set the gold standard in the production of plasma-derived products. In 2013, we submitted for licence approval in Europe, Canada and Australia for our first recombinant human protein.

Which patient groups benefit from such products?


Our portfolio focuses on immunoglobulins to treat patients with primary and secondary immune disorders and prevent rhesus incompatibility in pregnancies; coagulation factors to treat patients with bleeding disorders; and plasma and plasma proteins used to restore coagulation function and prevent shock.

What are the challenges of developing human proteins?

Collecting sufficient amounts of human plasma from healthy donors is an important task. To produce pharmaceuticals from a biological substance like blood plasma is challenging because the raw material is not standardised. With the patient in mind, stringent quality processes – from blood donation through to robust manufacturing – are vital.

How does the newly trialled Heidelberg Assay Panel (HAP) test aim to help those with relapsing multiple sclerosis?

The HAP test is expected to have the potential to predict responders to intravenous immunoglobulin treatment and to distinguish them from non-responders. In this way, it may be possible to only treat patients who will benefit from treatment and save unnecessary costs for healthcare systems. The test is based on a single small blood sample, and assesses a combination of genomic and functional immune parameters. With this HAP test, Octapharma makes its first steps into the field of personalised medicine for patients suffering from this debilitating condition.

Are there any other areas of R&D currently in the pipeline?

The underlying principle of Octapharma’s R&D is the development of therapies to treat diseases within our therapeutic areas. These therapies are based on human proteins either purified from human plasma or produced by recombinant technologies applied to human cell lines. Other innovations under development include a fully pharmaceutically licensed, SD-treated, freeze-dried, non-blood-type-specific plasma in bags; a new fibrinogen product; and a human granulocyte colony-stimulating factor product.

What motivates you?

The plasma industry develops life-saving treatments that significantly enhance the quality of life for patients. Working in a truly international, fast-growing company with highly motivated people, short reporting lines and fast decisionmaking is highly motivating for me.

How do you think the industry will change over the next five years?

Supply of enough plasma will continue to be an issue; in an attempt to address this, most manufacturers are increasing their plasma collection and manufacturing capacities to cope with increasing demands. Our fundamental principle of improving patient care means we are constantly developing our portfolio to meet the growing and changing global demand.

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Stefan Wietek is Head of Corporate Medical and Scientific Affairs at Octapharma and has 12 years of experience in the plasma industry. With a PhD in Molecular Biology, Stefan worked for Baxter’s Medical Affairs Europe department in 2002, before joining Octapharma three years later.
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