Proof of Concept Study Shows Protection with Influenza Vaccine

COLUMBIA, Md., April 24, 2013 /PRNewswire/ -- Royal DSM, a global life sciences and materials sciences company, announced today the results of a proof of concept study that demonstrated efficacy of an influenza vaccine developed and produced by a commercial microalgal platform system. The study results were published today in the peer-reviewed journal, PLOS ONE. In this study, the researchers used DSM's proprietary Schizochytrium platform to produce a subunit influenza vaccine capable of preventing disease in mice. Schizochytrium is currently used to produce nutritional lipids for supplements and fortification of foods. The vaccine was made using this basic commercial process, which is faster and less expensive than other comparable pharmaceutical processes.

"Higher-yield, lower-cost, and faster influenza vaccine production processes are critical to meet the global supply and surge production capabilities needed to counter global epidemic and pandemic threats," says Casey Lippmeier, a senior scientist at DSM who led the study.

This new Schizochytrium cell-based process has the potential to reduce vaccine scale-up and manufacture to less than half the time of the current egg-based system.  Traditionally, common influenza vaccines have been created from inactivated or attenuated preparations of live virus cultured in chicken eggs.  The current egg-based system is a labor intensive process requiring one or two eggs per vaccine dose and more than six months to scale-up for commercial manufacturing. 

"This production system facilitates development of new flu vaccines with earlier availability ahead of flu season, multivalent formulations for protection against a greater number of flu strains, and potentially better matching of the flu vaccine to the strains circulating in a given year," said Lippmeier.

Proof of Concept Study
The published study, Vaccination against Influenza with Recombinant Hemagglutinin Expressed by Schizochytrium sp. Confers Protective Immunity, can be found online at  http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0061790.  In this study, recombinant hemagglutinin proteins of influenza virus were expressed in the microalga Schizochytrium sp., an established, fermentable organism which is routinely grown in large commercial scale (>150,000 L). Schizochytrium cells were capable of secreting full-length, membrane-bound, influenza proteins in a readily usable form for vaccine formulation. One recombinant hemagglutinin (rHA) protein derived from A/Puerto Rico/8/34 (H1N1) influenza virus was evaluated as a vaccine in a mouse challenge model.  Mice were vaccinated with a single dose of 1.7, 5 or 15 micrograms of rHA vaccine, with or without adjuvant, and then challenged with lethal levels of homologous H1N1 virus.  80-100% of the vaccinated mice survived the challenge.  Complete protection (100%) was achieved in all dose groups, with and without adjuvant, after a second vaccination.  These data demonstrate the potential of Schizochytrium sp. as a platform for the production of ready-to-use recombinant antigens for vaccination against influenza.

Schizochytrium
Schizochytrium sp. is a robustly fermentable eukaryote, best known for its ability to accumulate large amounts of cellular triglyceride containing nutritionally important polyunsaturated fatty acids (PUFA); most notably, docosahexaenoic acid (DHA). The majority of Schizochytrium-derived triglyceride oil is used to fortify foods with DHA. Schizochytrium biomass has also found use in animal applications, most commonly as a blend in poultry or aquaculture feeds to increase levels of DHA in eggs or farmed seafood, respectively. Ten tons of triglyceride oil have been produced per annum using Schizochytrium grown in fully defined, protein-free, liquid media exceeding 150,000 liter scale.  The organism is highly efficient at consuming nutrients in the presence of low dissolved oxygen levels, with a reported peak rate of 9 doublings per day. This productivity translates into lower energy, materials, and labor costs.  The oil derived from Schizochytrium are GRAS-approved with a history of beneficial use in both human and consumption.

DSM – Bright Science. Brighter Living.™
Royal DSM is a global science-based company active in health, nutrition and materials.  By connecting its unique competences in Life Sciences and Materials Sciences, DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders.  DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, pharmaceuticals, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials.  DSM's 22,000 employees deliver annual net sales of around €9 billion.  The company is listed on NYSE Euronext. More information can be found at www.dsm.com.

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SOURCE Royal DSM