The production process

The donor’s identity is verified; details are managed in our donor registry system.

Donors must be: +18 years old, +50kg in weight and healthy.

Each donor completes a health questionnaire and physical screening.

The donation process takes 45 to 90 minutes. From 300 to 880ml of plasma is taken each time.

Donations are labelled with a barcode so at any point in the process the donor can be traced.

The plasma is tested for viruses like hepatitis, HIV and parvo virus B19.

As a first step, individual plasma donations are visually inspected.

After the visual inspection each donation is barcode scanned and all plasma codes are entered into the Octapharma production data system.

Donations are stored in a freezer at -25°C.

Single donation control (SDC) is the foundation of traceability of all of our individual plasma donations. Learn about the process from Annabelle, who works at our Lingolsheim site (France). 

Biochemical processes to separate plasma into its various components to gain the desired proteins for Octapharma products.

Fractionation is the separation of plasma proteins by influencing their solubility, by changing the ethanol concentration, pH-value and temperature. Different proteins are separated in different condiditons. Knuth Litke, Fractionation Manager, Springe (Germany) explains more in his video.

Different processes are used to filter out contaminants and pathogens:

• Precipitation

• Ultra/diafiltration

• Chromatography

To remove or inactivate viruses the following processes are used:

• Solvent detergent

• Nanofiltration

• Low pH

While purifying our products during a night shift at our site in Stockholm (Sweden), Process Operator Thomas explains the process:

In fine fractionation, we take the intermediates we receive from basic fractionation and purify them into final products.

Learn how intermediates are purified and transformed into products by watching his video.

Octapharma is investing in new state-of-the-art filling lines for our production sites. The aim is that fully automated lines will increase filling capacity, which ultimately means we can produce more products for patients. Sara, Inter-site Team Member, in Stockholm (Sweden) explains in this video how eliminating human contact from the filling process is key for our patients’ safety.

The finished product is inspected for contamination and damage, and approved based on authority requirements.

Products are packed into boxes and stored in cold rooms or freezers at required temperatures.

Every batch of final product is tested for compliance and patient safety.

100% review of all  process parameters.

Compliance with all requirements leads to internal release of the batch.

Samples of every plasma pool are re-verified for absence of viral markers as well as for virus DNA/RNA.

Batches are also tested externally and released by an Official Medicine Control Laboratory (OMCL).

To release the batch of final product, an external control of all defined criteria is required. After this, the medicines can be used by patients.

Performing analytical methods to test quality is the main task of the Quality Control Analytics department. “Our daily work is the testing of final containers, intermediates, in-process samples, and stability samples” says Bernhard, Senior Technician, at our Vienna site (Austria). Learn how this is done by watching his story.

Patients all around the world rely on our life-saving or life-enhancing treatments.

• 1,000,000+ people worldwide are living with bleeding disorders such as hemophilia.

• 300+ immune diseases are treated with our products.

• 1,200 plasma donations are needed to treat a severe hemophilia A adult patient with prophylaxis for one year.