Plasma-derived medicinal products are proteins extracted from blood and used as medicine to treat patients suffering from a range of diseases.
Composition of blood
Blood consists of approx. 45% cells and 55% liquid. There are three types of blood cells: red blood cells (erythrocytes), white blood cells (leukocytes) and platelets (thrombocytes).
Treatment using blood
Plasma is the liquid component of blood and is a clear yellowish/light brown colour. Minerals, carbohydrates, vitamins, fats and several types of protein are all present in plasma. It is common knowledge that some diseases are due to patients lacking certain proteins. These patients can, therefore, be treated using proteins extracted from blood plasma.
Proteins from blood plasma
Various proteins offering a range of functions can be isolated from blood. These proteins can be subdivided into four groups:
- Coagulation factors: proteins which together with platelets cause the blood to coagulate
- Immunoglobulins: proteins which protect the body against infections, but also influence the way the immune system works
- Albumin: protein that helps regulate the volume of blood
- Protease inhibitors: proteins which inhibit certain reactions occurring in our bodies
Doctors prescribe medicines derived from blood for the treatment of approximately 100 different diseases. Some patients are unable to produce either sufficient or the correct proteins and are, therefore, administered extra proteins from donor blood. This form of therapy is referred to as replacement therapy.
Healthy people have a balance between the production and breakdown of the proteins which are needed on a daily basis.
If there is a production disorder, a person may have too few proteins. Generally this is a congenital condition and the patient will require treatment with medicines derived from blood for his or her entire life.
Examples of production disorders are:
• Hereditary coagulation disorders such as haemophilia.
• Hereditary immunodeficiency diseases such as Bruton disease (X-linked agammaglobulinemia).
These patients produce no or insufficient immunoglobulins (antibodies). Due to this reduced defence, these patients are particularly prone to infections. To prevent such infections, these patients are administered immunoglobulins isolated from donor blood.
• Inherited complement disorders accompanied by attacks of swelling (angioedema). Patients with a deficiency or dysfunction of the C1-esterase inhibitor are affected by recurring attacks of oedema (swelling). This can be a visible swelling of the face, throat and limbs, but can also occur internally. Internal swelling can manifest itself as painful abdominal distress or intestinal disorders. Oedema attacks can be treated with a C1-esterase inhibitor isolated from donor blood.
Sometimes imbalances arise due to very different causes. For example:
This can cause the volume of blood circulating to be inadequate for good tissue perfusion. The tissue then receives insufficient oxygen and dies off. The disturbance of the blood circulation could be caused by a loss of blood (accidents, operations) or the expansion of blood vessels (burns, sepsis). To restore and maintain the correct volume of blood, a patient may be treated with albumin extracted from donor blood.
• Acute correction anticoagulation therapy
One of the functions of blood is to ensure coagulation as soon as a blood vessel is damaged. However, sometimes blood coagulates despite no blood vessels being damaged. A blood clot which appears in an undamaged blood vessel, is referred to as a thrombosis. When a blood clot is formed it disrupts the flow of blood. This can occur in various places in a body; examples include: thrombosis in the leg, a pulmonary embolism or a stroke (brains). Coagulation can be restored using a prothrombin complex isolated from donor blood.
• Derailing reactions in a body
Sometimes you want to prevent an imbalance. An example of this is passive immunisation. By administering specific antibodies, a person is protected against a potential imbalance occurring. The specific antibodies that are administered provide direct protection without the body having to activate its own immune system.
• preventing Hepatitis A
• preventing chickenpox
• preventing tetanus
• preventing the breakdown of erythrocytes in rhesus positive children with rhesus negative mothers
Principles for the production of blood-derived medicines
Blood can transmit diseases. It is of the essence to prevent the causes of these diseases being present in blood products or plasma-derived medicinal products. SPP has an extensive and stringent quality system to guarantee safety and reliability, both for patients and employees. Consequently, the production processes in our modern pharmaceutical factory comply with the highest quality requirements and are monitored by Dutch, European and American institutions.