The process for the manufacturing of plasma protein comprises the following key steps:
The raw material for plasma proteins is human blood plasma. Biotest collects the majority of the plasma it needs for its own production through a process called plasmapheresis at dedicated donation centres. This process uses a machine that separates the plasma from donated blood, and the remaining components of the blood are returned to the donor’s circulation. This process allows a donor to give plasma up to twice weekly.
To ensure the highest possible safety, the plasma used is taken exclusively from qualified donors, i.e. donors whose health is continuously monitored. Before processing, donated plasma is tested multiple times for possible contamination with viruses or other contaminants, using the very latest testing technology.
Fractionation / manufacturing
The plasma goes through several complex processes during manufacturing to separate it into its individual components, such as clotting factors, immunoglobulins or other substances (e.g. albumin) which are then filled into bottles under sterile conditions. All this takes place in our modern facilities in Dreieich, Germany.
The international facilities form a production network: on one side plasma is collected and processed into certain end-products in the USA and other unused intermediates from the USA are processed into other end-products and marketed in Dreieich. This ensures efficient manufacturing that optimises the use of plasma which is a precious resource. It also allows Biotest to market plasma proteins in countries that only authorise products made from plasma collected in the USA.
Biotest develops new drugs in the three therapeutic areas of clinical immunology, haematology and intensive care medicine. We are constantly reviewing and developing our current range of products to adapt to unmet needs and new indications.
Over many years we have developed expertise and deep knowledge in many areas involved in manufacture and development of plasma derived products such as: clinical research and development, regulatory affairs, drug safety. Specialists from the various departments collaborate in interdisciplinary teams for each individual development project.
This is described in more detail under “Research and development”.