Seqirus, a leading innovator in influenza vaccines and pandemic
preparedness, today announced the next major advancement in the use
of cell-based technology at its state-of-the art manufacturing
facility in Holly Springs, North Carolina.
This Smart News Release features multimedia.
View the full release here:
http://www.businesswire.com/news/home/20170621005754/en/
(Photo: Seqirus)
In an industry first, Seqirus has successfully produced
cell-based influenza vaccine at commercial scale using a candidate
vaccine virus (CVV) that has been isolated and grown in cells,
rather than in eggs.1,2 CVVs are prepared by the World Health
Organization (WHO) Global Influenza Surveillance and Response
System (GISRS) and associated laboratories, and are used by
manufacturers to develop and produce influenza vaccines.
The use of cell-derived CVVs, rather than egg-derived CVVs, has
the potential to drive improved process control and increased
output in the production of cell-based influenza vaccines. In
addition, influenza viruses isolated and grown exclusively in cells
can be more similar to influenza viruses in circulation.3,4
Since first beginning production in 2014, the Holly Springs site
has used egg-derived CVVs in its cell-based manufacturing process.
In 2016, the WHO began to also recommend cell-derived CVVs and the
US Food and Drug Administration (FDA) issued an approval for
Seqirus to use them in the production of cell-based influenza
vaccines at Holly Springs.4,5
This year, Seqirus was successful in using a cell-derived H3N2
CVV in the production of its cell-based seasonal influenza vaccine,
making the end-to-end production of this particular strain
exclusively cell-based.1 The company plans to utilize cell-derived
CVV technology for the production of other vaccine strains produced
at the Holly Springs site in the future.
“Cell-based influenza vaccines represent one the most
significant advancements in the history of influenza vaccine
production. Seqirus is proud to continue to innovate this promising
technology as part of our leading role in influenza prevention and
pandemic preparedness,” said Gordon Naylor, President of
Seqirus.
“The successful application of this new technology reflects the
deep expertise that exists within Seqirus, developed over our
100-year heritage in influenza. It will improve our overall
production process and enhance our ability to deliver on our
commitment to public health.”
The Holly Springs facility was purpose-built in partnership the
U.S. Biomedical Advanced Research and Development Authority (BARDA)
to help combat pandemic threats.6,7 This latest milestone is the
result of a multi-year collaboration involving the WHO
Collaborating Centre for Surveillance, Epidemiology and Control of
Influenza at the U.S. Centers for Disease Control and Prevention
(CDC), the WHO Collaborating Centre for Reference and Research on
Influenza in Melbourne, Australia, and scientists at Seqirus and
its predecessor company. The cell-based H3N2 CVV used by Seqirus
was developed by the WHO Collaborating Centre in Melbourne from a
sample originally obtained from the National Influenza Centre in
Singapore.
“This major advancement would not have been possible without
significant global collaboration and is a fine example of how
industry and public health agencies can work together to better
combat influenza,” said Naylor.
About Seasonal InfluenzaInfluenza is a common, contagious
infectious disease that can cause severe illness and
life-threatening complications in many people. To reduce the risk
of more serious outcomes, such as hospitalization and death,
resulting from influenza, the CDC recommends annual vaccination for
all individuals aged six months and older.8 Because transmission to
others may occur one day before symptoms develop and up to five to
seven days after becoming sick, the disease can be easily
transmitted to others.8
Influenza can lead to clinical symptoms varying from mild to
moderate respiratory illness to severe complications,
hospitalization and in some cases death.8 The CDC estimates that
310,000 people in the United States were hospitalized due to
influenza-related complications during the 2015-2016 influenza
season.9 Since it takes about two weeks after vaccination for
antibodies to develop in the body that protect against influenza
virus infection, it is best that people get vaccinated to help
protect them before influenza begins spreading in their community,
and by the end of October if possible.8
About SeqirusSeqirus is part of CSL
Limited (ASX:CSL), headquartered in Melbourne, Australia. The
CSL Group of companies employs almost 20,000 people and supplies
life-saving medicines to more than 60 countries.
Seqirus was established on 31 July 2015 following CSL’s
acquisition of the Novartis influenza vaccines business and its
subsequent integration with bioCSL. As the second largest influenza
vaccine provider in the world, Seqirus is a major contributor to
the prevention of influenza globally and a transcontinental partner
in pandemic preparedness.
Seqirus operates state-of-the-art production facilities in the
US, the UK and Australia, and manufactures influenza vaccines using
both egg-based and cell-based technologies. It has leading R&D
capabilities, a broad portfolio of differentiated products and a
commercial presence in more than 20 countries.
For more information
visit www.seqirus.com and www.csl.com.
Media InformationInterviews with Gordon Naylor, Seqirus
President, and Ethan Settembre, Seqirus Vice-President of Research,
can be arranged through Nate Gilbraith, +1 (612) 455-1915,
Nate.Gilbraith@padillaco.com or Kim Blake, +1 (757) 635-5658,
kim.blake@padillaco.com.
Further images and b-roll footage of the Holly Springs facility
be downloaded from: http://www.seqirus-us.com/images-broll.htm
References
1 US Department of Health & Human Services. Supplement
Approval. Available at
https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM522280.pdf.
Accessed May 2017.
2 Ambrozaitis A, et al. A novel mammalian cell-culture technique
for consistent production of a well-tolerated and immunogenic
trivalent subunit influenza vaccine. Vaccine. 2009;27:6022–6029.
doi:10.1016/j.vaccine.2009.07.083.
3 Barr et al. WHO recommendations for the viruses used in the
2013-2014 Northern Hemisphere influenza vaccine: Epidemiology,
antigenic and genetic characteristics of influenza A(H1N1) pdm09,
A(H3N2) and B influenza viruses collected from October 2012 to
January 2013. Available at:
http://www.sciencedirect.com/science/article/pii/S0264410X1400187X?via%3Dihub.
Accessed June 2017.
4 World Health Organization. Improving influenza vaccine virus
selection, Report of the 4th WHO Informal Consultation Hong Kong.
Available at
http://www.who.int/influenza/resources/publications/Influenza_vaccine_virus_selection_report/en/.
Accessed June 2017.
5 World Health Organization. Recommended composition of
influenza virus vaccines for use in the 2017-2018 northern
hemisphere influenza season. Available at
http://www.who.int/influenza/vaccines/virus/recommendations/201703_recommendation.pdf?ua=1.
Accessed June 2017.
6 US Department of Health & Human Services. A milestone in
protection from influenza. US Department of Health and Human
Services website. Available at:
http://www.hhs.gov/news/press/2014pres/06/20140617a.html. Accessed
April 2016.
7 This project has been funded in whole or in part with Federal
funds from the Office of the Assistant Secretary for Preparedness
and Response, Biomedical Advanced Research and Development
Authority, under Contract No. HHSO100200900101C.
8 Centers for Disease Control and Prevention (CDC). “Key Facts
About Seasonal Flu Vaccine.” Available at:
http://www.cdc.gov/flu/protect/keyfacts.htm. Accessed June
2017.
9 CDC. “Seasonal Influenza-Associated Hospitalizations in the
United States.” Available at:
https://www.cdc.gov/flu/about/qa/hospital.htm. Accessed June
2017.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170621005754/en/
For Seqirus:Nate Gilbraith, +1
612-455-1915Nate.Gilbraith@padillaco.comorKim Blake, +1
757-635-5658kim.blake@padillaco.com
CSL (ASX:CSL)
Historical Stock Chart
From Mar 2024 to Apr 2024
CSL (ASX:CSL)
Historical Stock Chart
From Apr 2023 to Apr 2024