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 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 facilities in Dreieich, Germany.
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”.