GlaxoSmithKline Biologicals Dresden

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GlaxoSmithKline Biologicals Dresden
(GSK Bio Dresden)
Saxon Serum Factory Dresden
(SSW Dresden)
legal form
founding 1911 (as Saxon Serum Factory and Institute for Bacteriotherapy )
Seat Dresden , GermanyGermanyGermany 
Number of employees approx. 700 (2008)
Branch Vaccine manufacturer
Website www.glaxosmithkline.de

GlaxoSmithKline Biologicals Dresden (GSK Bio Dresden) is a subsidiary of the British group GlaxoSmithKline (GSK) and belongs to the GSK Biologicals (GSK Bio) division responsible for vaccines. The company, which was founded in Dresden in 1911 , was known as Sächsisches Serumwerk Dresden (SSW Dresden) until 2008 and produces flu vaccines for up to 70 countries, including the USA .

History and Development

SSW Dresden 2007
GSK Bio Dresden 2009

GlaxoSmithKline Biologicals Dresden is one of the traditional pharmaceutical companies in Saxony , along with the Dresden pharmaceuticals works , and was founded in 1911 as the Saxon Serum Works and Institute for Bacteriotherapy by Karl August Lingner in downtown Dresden. As early as the 1920s, it was known as Sächsisches Serumwerk Dresden, one of the most important sera and vaccine producers in German-speaking countries. In the thirties, the Oelzschau branch was added with a large number of animals for serum production.

By 1936, 90 different vaccines, antitoxic serums, drugs and diagnostic tests were made:

Influenza vaccine has been part of the portfolio since 1975 .

In 1992 the factory was sold by the trust to the British group SmithKline Beecham after it had been nationalized relatively late in 1972 during the GDR era. In 2000 SmithKline Beecham merged with Glaxo Wellcome and the resulting group GlaxoSmithKline plc. took over the location.

In the summer of 2005, the group decided to invest around 100 million euros in the plant in order to be able to double the current capacity of 30 million vaccine doses of the flu vaccine by 2009 and to create 170 jobs. Among other things, the new building must also meet the strict requirements of the FDA in order to be able to produce for the US market.

2005–2007 newly built part of the SSW Dresden building

The new building was inaugurated by Prime Minister Georg Milbradt at the end of 2007 and routine operations began in early 2008. During the main production time, around 700 employees now work in three shifts on the vaccine production. Every year around 70 million doses of the seasonal flu vaccine (out of a total of 500 million produced worldwide) are produced in this way.

In 2007 and 2008, patents were registered for the composition of the vaccine.

In 2008 the name Sächsisches Serumwerk Dresden, which had been used for a long time, was dropped and adapted to the parent company GSK. The official name of the site is now GlaxoSmithKline Biologicals Dresden (GSK Bio Dresden).

Compared to the historic location on Pillnitzer Strasse in the Pirnaische Vorstadt , the company had planned in 2009 to build an additional production facility for more than 100 million euros from 2012 and to create another 100 jobs. Due to the city center location, the pharmaceutical company would have to meet strict requirements in terms of safety, noise protection and flood protection. For example, nothing should be produced on the ground floor of the factory. A new generation of flu vaccines should be manufactured at the plant. In 2014 GlaxoSmithKline said the realization of the construction project was questionable, as the economic basis for this investment was lacking due to falling sales figures.

production

Overview of production

In the past, a wide variety of pharmaceutical products were manufactured in the factory; in 1936 there were 90 vaccines, antitoxic serums, drugs and diagnostic tests. On behalf of SmithKline Beecham z. B. manufactured the liver and biliary agent Cholecysmon®, today (2009) by RIEMSER Arzneimittel AG .

Since 1990 ( turning point , end of the GDR), production has concentrated more and more on flu vaccines, the development and improvement of which is also being pushed forward (e.g. preservative-free manufacturing process since 2003). Furthermore, other liquid vaccines (as opposed to freeze-dried vaccines) are packaged and delivered for the parent company, e.g. B. Havrix® hepatitis A vaccine.

Seasonal flu vaccine

GSK Bio Dresden has been producing vaccines against real flu (influenza) since 1975 , and has also been preservative-free since 2003. Since influenza viruses are constantly changing, the vaccine is made to suit the coming flu season, i.e. the next winter. Since winter is at different times in the northern and southern hemispheres, provisions are made for two flu seasons: for the coming winter in the northern hemisphere , production takes place in spring / summer. For the coming winter of the southern hemisphere , the vaccine will be produced in autumn / winter.

The WHO issues recommendations for the composition of the vaccine for each season every six months. Three virus types (subtypes) from two virus genera (type A and B) are selected, which often cause infections in humans. Since these three types are in a vaccine, it is also called trivalent.

The viruses are multiplied and processed to produce the vaccine . The finished vaccine is then filled into pre-filled syringes or ampoules and packaged. Since the composition varies from season to season, an approval process (in Germany at the Paul Ehrlich Institute (PEI) ) with clinical trials must be completed so that the vaccine can be sold and used.

In Germany, the flu vaccine is sold by GSK Bio Dresden under the trade name Influsplit SSW ®. Outside Germany, the vaccine is sold under the trade name Fluarix ® and in some countries, e.g. B. Belgium, sold under the trade name Alpharix ® or alpha-Rix ®. Since the vaccine is composed differently from season to season, the respective season is added to the trade name, e.g. B. Influsplit SSW ® 2006/2007 or season and abbreviation for northern / southern hemisphere: Fluarix ® SH 2008 (SH = southern hemisphere , NH = northern hemisphere ).

A Canadian subsidiary of GSK Bio also produces influenza vaccines and has been selling it under the trade name Fluviral ® in Canada since 2005 and under the trade name FluLaval ® in the USA since October 2006.

(Pre-) pandemic flu vaccine

Since there is only one virus subtype in these flu vaccines, they are monovalent vaccines compared to the trivalent vaccine against seasonal flu. The (pre) pandemic vaccines should be used as a prophylactic measure in the event of an influenza pandemic or in advance.

In March 2007, the company received European approval to manufacture a pandemic vaccine under the trade name Daronrix ®. This was allowed to be administered in the event of a pandemic (phase 6). Luxembourg and Switzerland bought the vaccine of the virus subtype H5N1 as a precautionary measure, as a pandemic could be feared due to the H5N1 avian flu that had just occurred . Daronrix is ​​no longer approved because it was not marketed.

The first pre- pandemic vaccine was approved in May 2008. Also made with the then current subtype Influenza A virus H5N1 , Prepandrix ® can be used in the case of a human-to-human H5N1 bird flu, even before the pandemic was declared by the WHO ( before phase 6). The aim is to achieve a first immunization with the virus subtype used until the vaccine with the virus subtype that actually triggers the pandemic is available. To speed up the manufacturing and approval process, a “ prototype vaccine” (also known as a mock-up file) was approved in May 2008 under the name Pandemrix ® with the virus subtype H5N1. With this prototype z. B. an H1N1 vaccine can also be produced and approved.

Since May 2009 preparations have been made for the production of a pandemic vaccine against the current spread of "swine flu" of the virus subtype A / H1N1.

Individual evidence

  1. ↑ Dr. Volker Ruhland, Prof. Dr. Ulrich Schneeweiß: On the history of the Saxon Serumwerk Dresden. The development of the Serumwerk from its foundation to 1945. :: Publisher: Sächsisches Serumwerk Dresden (NL of SmithKline Beecham GmbH & Co. KG).
  2. ↑ GlaxoSmithKline is investing almost 100 million euros in the Sächsisches Serumwerk Dresden . bionity.com. August 17, 2005. Retrieved May 20, 2009.
  3. ↑ a b Project: New factory building for the production of flu vaccine (DR02) . lsmw.de. Archived from the original on May 30, 2009. Retrieved May 20, 2009.
  4. ↑ 2007-10-10: Opening in the Sächsisches Serumwerk / Dresden GSK location doubles capacities for flu vaccines . med-kolleg.de. October 10, 2007. Retrieved May 20, 2009.
  5. ↑ Influenza vaccine composition US 7316813 B2
  6. ↑ Influenza vaccine composition CA 2448208 C
  7. ↑ Pharmaceutical company invests more than 100 million in new Dresden serum factory , Denni Klein. In: Sächsische Zeitung of April 17, 2009
  8. ↑ Nadine Steinmann: GlaxoSmithKline Dresden puts 100 million euro expansion on hold due to falling sales. April 10, 2014, accessed April 30, 2015 .
  9. ↑ a b History of GSK Bio Dresden . GlaxoSmithKline Germany. Retrieved May 20, 2009.
  10. ↑ Ronald A. Rader: Monograph of the Dresden flu vaccine. (No longer available online.) Biopharma, formerly in the original ; Retrieved December 30, 2008 .  ( Page no longer available , search in web archives )  Info: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice.@1@ 2Template: Dead Link / 208.69.231.70  
  11. ↑ Information on "Fluviral" . GlaxoSmithKline . Archived from the original on December 23, 2008. Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. Retrieved December 30, 2008.  @1@ 2Template: Webachiv / IABot / www.gsk.ca
  12. ↑ Information on "FluLaval" . GlaxoSmithKline . Archived from the original on September 27, 2007. Retrieved December 30, 2008.
  13. ↑ "Daronrix" summary page . European Medicines Agency . Retrieved May 20, 2009.
  14. ↑ EMA: Daronrix Public statement - Cessation of MA
  15. ↑ a b "Prepandrix" overview page . European Medicines Agency . Retrieved December 30, 2008.
  16. ^ "Prepandrix" product information . European Medicines Agency . Retrieved December 30, 2008.
  17. ↑ GSK pandemic information mock-up file . GlaxoSmithKline Germany. May 2, 2009. Archived from the original on February 28, 2010. Retrieved on May 20, 2009.
  18. ↑ The Pandemrix vaccine ordered will be delivered in October 2009. GSK pandemic information . GlaxoSmithKline Germany. Archived from the original on November 14, 2009. Retrieved May 20, 2009.

literature

  • Volker Ruhland, Ulrich Schneeweiß: On the history of the Saxon Serumwerk Dresden. Sächsisches Serumwerk (Ed.), Dresden 2001

Web links

Coordinates: 51 ° 3 '2.7 "  N , 13 ° 45' 1.9"  E