The production process
We collect plasma and manufacture it into lifesaving plasma-derived therapies.
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Each plasma-derived therapy we create is controlled, fractionated, purified, virus inactivated and inspected before being used to change and save the lives of millions of patients worldwide.
Plasma-based therapies treat rare, genetic and chronic diseases such as haemophilia and immune deficiency disorders. They are also used for trauma and burn victims and for critical care procedures including major surgeries, cancer treatments and organ transplants
Identification
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.
Screening
Each donor completes a health questionnaire and physical screening.
Donation
The donation process takes 45 to 90 minutes. From 300 to 880ml of plasma is taken each time.
Organising
Donations are labelled with a barcode so at any point in the process the donor can be traced.
Testing
The plasma is tested for viruses like hepatitis, HIV and parvo virus B19.
Visual inspection
As a first step, individual plasma donations are visually inspected.
Scanning
After the visual inspection each donation is barcode scanned and all plasma codes are entered into the Octapharma production data system.
Storage
Donations are stored in a freezer at -25°C.
Controlling the plasma that enters production
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).
Processing plasma
Biochemical processes to separate plasma into its various components to gain the desired proteins for Octapharma products.
Separating plasma proteins
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.
Purification processes
Different processes are used to filter out contaminants and pathogens:
Precipitation
Ultra/diafiltration
Chromatography
Virus removal
To remove or inactivate viruses the following processes are used:
Solvent detergent
Nanofiltration
Purifying products
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.
The filling process
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.
Visual inspection
The finished product is inspected for contamination and damage, and approved based on authority requirements.
Packaging
Product are packed into boxes and stored in cold rooms or freezers at required temperatures.
Testing
Every batch of final product is tested for compliance and patient safety. All specified parameters are tested 100%.
Review
100% review of all process parameters.
Internal release
Compliance with all requirements leads to internal release of the batch.
Re-verification
Samples of every plasmapool are re-verified for absence of viral markers as well as for virus DNA/RNA.
External testing
Batches are also tested externally and released by an Official Medicine Control Laboratory (OMCL).
External control
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
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.
Providing help
Patients all around the world rely on our products to live a normal life.
1,000,000+ people worldwide are living with bleeding disorders such as haemophilia.
300+ immune diseases are treated with our products.
1,200 plasma donations are needed to treat a severe haemophilia A adult patient with prophylaxis for one year.