samedan logo
 
 
 
spacer
home > ebr > spring 2014 > human impact
PUBLICATIONS
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.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
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.
spacer
Stefan Wietek
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Bio-Rad Launches Its CFX Opus Dx Real-Time PCR Detection Systems for In Vitro Diagnostics

HERCULES, Calif.–October 21, 2021–Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced the launch of the CFX™ Opus 96 Dx System and the CFX™ Opus 384 Dx System
More info >>

White Papers

ConsulTech GmbH

ConsulTech GmbH

ConsulTech is a consulting company founded in 1992. Since then, we have been supporting biotech-nology, pharmaceutical and medical technology companies as well as research institutions with the entire process of setting-up and executing proposals for R&D projects. In projects funded by the European Commission, ConsulTech supports the coordinator by resuming administrative tasks allow-ing coordinators and partners to fully concentrate on the scientific and technical success of the pro-ject. We solve financial and administrative issues, organise meetings, take care of the timely delivery of milestones and reports and much more.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement