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Quality products start with quality plasma

 

All medicines are associated with some risks. With plasma-derived products, there is a potential risk of contamination with infective agents that may originate from the donated plasma.  While the theoretical risk of transmission of infective agents can never be totally excluded, Octapharma incorporates multiple safety measures to reduce this risk to as low as possible.

 

The Octapharma Quality Plasma System comprises:

 

Carefully selected donor centres

Plasma suppliers are selected with utmost care. Octapharma procures about 80% of its plasma from company-owned Plasma Donation Centres in Germany and the USA. All plasma suppliers are licensed by national Health Authorities, and operate in compliance with current EU and/or FDA GMP (Good Manufacturing Practice) requirements.

 

Selection of healthy donors

All donors are interviewed with regard to their medical and lifestyle history, and are only accepted for donation if they are healthy and free of risks for blood-borne diseases. By using state-of-the-art test methods each donation is screened for absence of HIV, HBV and HCV. Almost all of them are in addition also tested for HAV and Parvo B19.

 

Confirmation of plasma quality

Plasma is prepared from whole blood donations or is directly obtained by automated plasmapheresis. It is free from detectable viruses, and contains specified levels of protective antibodies, coagulation factors and other important proteins. Following collection, plasma is rapidly frozen to preserve unstable proteins. It is maintained at -20°C or below during all storage and transport in a well controlled ‘cold chain’ system. Only plasma that meets all specified quality and safety criteria which also includes a 100% single donation control on site is released for production processes at Octapharma plants.

 

Small plasma batches

For both quality and viral safety reasons, Octapharma works with small plasma batches that are pooled by country of origin. All plasma batches are again tested for the absence of viral markers and by state-of-the-art PCR methods. The ability to work with small plasma batches makes Octapharma an ideal partner for small and medium-sized toll fractionation projects. Current partners include:

 

  • Finnish Red Cross (production of octaplas® , octaplas LG® and fractionation products from Finnish plasma) 
  • Slovenian Blood Transfusion Service (fractionation products from Slovenian plasma)
  • Luxembourg for Octaplas LG, Norway for both Octaplas and fractionation products, Mexico for fractionation products
  • Production of Omniplasma from Dutch plasma

 

 

Quality products start with quality plasma

 

The Octapharma Quality Plasma System comprises:

 

  • Carefully selected donor centres

Plasma suppliers are selected with utmost care. Octapharma procures about 80% of its plasma from company-owned Plasma Donation Centres in Germany and the USA. All plasma suppliers are licensed by national Health Authorities, and operate in compliance with current EU and/or FDA GMP (Good Manufacturing Practice) requirements.

 

  • Selection of healthy donors

All donors are interviewed with regard to their medical and lifestyle history, and are only accepted for donation if they are healthy and free of risks for blood-borne diseases. By using state-of-the-art test methods each donation is screened for absence of HIV, HBV and HCV. Almost all of them are in addition tested on HAV and Parvo B19.

 

  • High-quality plasma

Plasma is prepared from whole blood donations or is directly obtained by automated plasmapheresis. It is free from detectable viruses, and contains specified levels of protective antibodies, coagulation factors and other important proteins. Plasma is rapidly frozen to preserve unstable proteins. It is maintained at -20°C or below during all storage and transport in a well controlled ‘cold chain’ system. Only plasma that meets all specified quality and safety criteria which also includes a 100% single donation control on site is released for production processes at Octapharma plants.

 

  • Small plasma batches

For both quality and viral safety reasons, Octapharma works with small plasma batches that are pooled by country of origin. All plasma batches are again tested for the absence of viral markers and by state-of-the-art PCR methods. The ability to work with small plasma batches makes Octapharma an ideal partner for small and medium-sized toll fractionation projects. Current partners include:

  • Finnish Red Cross (production of octaplas® , octaplas LG® and fractionation products from Finnish plasma) 
  • Slovenian Blood Transfusion Service (fractionation products from Slovenian plasma)
  • Luxembourg for Octaplas LG, Norway for both Octaplas and fractionation products, Mexico for fractionation products
  • Production of Omniplasma from Dutch plasma