- Annual report 2016 PDF English8.4Mb
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On 1 February 2016, the World Health Organization (WHO) declared Zika virus (ZIKV) a public health emergency of international concern. The scientific consensus is that Zika virus, a mosquito-borne flavivirus first identified in humans in 1952, causes neurological disorders including microcephaly and Guillain-Barré syndrome.
Octapharma’s Virus & Prion Validation group in Frankfurt responded quickly by planning and executing studies to validate our existing viral inactivation/elimination processes against Zika. Octapharma uses a variety of dedicated viral inactivation and removal steps in our fractionation processes in order to ensure the viral safety of our plasma-derived products. For an enveloped virus, solvent detergent (SD) treatment is still, some three decades after introduction by Octapharma, the current gold standard in inactivation. For a virus larger than 20 nanometres, nanofiltration removes the virus.
As ZIKV is an enveloped virus SD treatment or pasteurisation are highly effective in inactivation, and as it is larger than 20 nanometres, nanofiltration is effective in eliminating it. Despite having the theoretical knowledge that our existing production processes will inactivate and remove the virus, it was important for us to demonstrate this scientifically and validate that our production techniques are successful in inactivating ZIKV.
Our whole scientific team was involved in the Zika studies. In a biosafety-level laboratory the safety steps were scaled down and the virus was added to intermediates of the respective production step. The viral inactivation techniques of SD treatment and pasteurisation (60°C) were applied, then we determined if the virus titre was below the detection limit and if the virus safety steps were sufficient to inactivate ZIKV. We completed studies for four Octapharma products, then analysed and collated the results from February until June 2016. The findings were very satisfying as our well-established virus inactivation steps were proved to be successful against ZIKV. The study results have been published in the “Transfusion” journal.
In our routine work we perform virus and prion validation studies for all Octapharma products, both plasma and recombinant, as well as new development products in the pipeline. We verify the efficacy of the viral inactivation or removal methods used in our production processes by performing Good Laboratory Practice compliant studies on a laboratory scale. In our studies we use samples of Octapharma products from the different production sites. In our labs we add various viruses to the product, including human immunodeficiency virus (HIV), West Nile virus (WNV) or hepatitis A (HAV), in order to perform our validation studies.
I know many people who don’t like to work in a biosafety-level laboratory but I enjoy it. I am fascinated to know that we are handling dangerous viruses which can cause fatal diseases. I am very proud to be part of a team which is responsible for the viral and prion safety of Octapharma’s products. Viral safety was the idea upon which Octapharma was founded. Our viral safety steps mean that no patient has to fear being infected with viruses from our products. I am proud to see our products helping so many patients all around the world. Mark Twain said: “Give every day the chance to become the most beautiful day of your life,” and I try to live up to this every day.