Proof of Concept Study Shows Protection with Influenza Vaccine

        Proof of Concept Study Shows Protection with Influenza Vaccine

Influenza vaccine produced using Schizochytrium platform technology

PR Newswire

COLUMBIA, Md., April 24, 2013

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
atwww.dsm.com.

For more information:

DSM
Anthony Martin
tel. + 1 443-542-2599
Mobile - +1 410-818-6999
email anthony.martin@dsm.com

Forward-looking statements
This press release may contain forward-looking statements with respect to
DSM's future (financial) performance and position. Such statements are based
on current expectations, estimates and projections of DSM and information
currently available to the company. DSM cautions readers that such statements
involve certain risks and uncertainties that are difficult to predict and
therefore it should be understood that many factors can cause actual
performance and position to differ materially from these statements. DSM has
no obligation to update the statements contained in this press release, unless
required by law. The English language version of the press release is leading.
Although DSM has used diligent care to ensure that the information provided
herein is accurate and up to date, this publication does not constitute or
provide scientific or medical advice and is distributed without warranty of
any kind, either expressly or implied.

SOURCE Royal DSM

Website: http://www.dsm.com
 
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