The production process

We collect plasma and manufacture it into lifesaving plasma-derived therapies.

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

Plasma donation

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.

Single donation control

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). 

Fractionation

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 and virus removal / inactivation

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.

Filling / finish

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 and packaging

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.

Quality control

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.

Patients

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.