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Octapharma submits marketing authorization application (MAA) to the EMA for the first truly human recombinant coagulation factor VIII from a human cell line

 

 

 

 

 

March 2013

Octapharma Group release 2012 Annual Report

 

 

 

 

 

 

 

 

 

 

February 2013

Two more new peer-reviewed publications on human cell line-derived recombinant human FVIII

 

 

 

 

 

 

September 2012

Peer-reviewed paper about our rhFVIII-Projekt

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

July 2010

Relocation of Octapharma Biopharmaceuticals GmbH to Heidelberg

Octapharma AG invests in the Technology Park Heidelberg

 

 

 

 

 

 

 

 

Octapharma AG submitted the marketing authorization application (MAA) for the first truly human recombinant coagulation factor VIII (FVIII) from a human cell line for the treatment of haemophilia A to the European Medicines Agency (EMA) on May 29th, 2013.

http://www.octapharma.com/en/about-octapharma/news-events/news-single-view.html?tx_ttnews%5Btt_news%5D=332&cHash=76e7393e88a4145e11ec3d7c95fabd96

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An impressive return of octagam® 5% and 10% consolidated the financial performance and financial position of the Octapharma Group in the year 2012. Significant increases in net sales combined with a good performance in the collection of trade receivables and sound investment decisions allowed the Octapharma Group to end the year 2012 with increased profitability, significantly without bank loans.

Annual Report

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It is with pleasure that we can announce the availability of two more peer-reviewed papers on our Human-cl rhFVIII as the first native and truly human cell-derived rFVIII. Beside the already available paper on the human cell line and manufacturing characteristics,

Paper 1

Paper 2

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The first peer-reviewed publication on Octapharma`s Human-cl rhFVIII has been published in the European Journal of Haematology.

The article can be read by clicking the following link:

“The first recombinant human coagulation factor VIII of human origin: human cell line and manufacturing characteristics”

The present paper addresses:

  • The rationale for developing a human instead of a hamster cell line for rFVIII production in order to reduce rFVIII immunogenicity
  • The rationale why the usage of the HEK 293F cell line may lead to less FIII inhibitors and allergic reactions than hamster cell-lines
  • How Octapharma managed to be the first company worldwide to adapt the HEK293F cell line for the commercial production of a high quality rFVIII
  • The extensive pathogen safety measures undertaken to guarantee the highest level of virus and prion safety
  • The capacity of the newly developed production and purification process in order to eliminate any potential contaminations of the final product
  • How it was possible to use the human cell line as a production cell line without adding any animal-or human-derived materials
  • How we developed the most modern manufacturing process for a truly human rFVIII to ensure the highest level of inhibitor safety, purity and pathogen safety

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Octapharma AG will invest more than 25 Million Euros in a new building of a research center in the Technology Park in Heidelberg. The foundation stone for the fourth construction phase of the technology park was laid on July 8 by Octapharma founder Wolfgang Marguerre, mayor Dr. Eckart Würzner, Carola Schröder general manager of Octapharma Biopharmaceuticals GmbH and the architects Bert and Björn Burger.

The initialization of the building in Heidelberg is shown in the video portal of the Rhein Neckar television. The Rhein Neckar newspaper reported the story of the foundation stone laying:” A dream boat to wing research” (published on July 9, 2010).
The opening of the new facility in direct vicinity to the German Cancer Research Center (DKFZ) is planned for the beginning of 2012. Main focus will be basic research in alignment with the company’s core competences: immunology, hematology/blood coagulation as well as intensive and emergency medicine. The stakeholder of the new research center is Octapharma Biopharmaceuticals GmbH, a biotech research company with its core competence in protein expression with human cell lines.General manager Carola Schröder and staff will move from Martinsried nearby Munich to Heidelberg and will recruit additional highly qualified employees from the metropolis region. With the opening of the new location it is intended to increase personnel. It is firstly planned to reach a head count of 60 employees, while later on up to 100 employees are to conduct research in Heidelberg.

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