Plasma is the raw material from which all of Kedrion’s activities flow. Without plasma we can neither help people nor employ them. Our major activities can be traced along the path of plasma flowing from donor to recipient. The highest standards of health and safety are maintained throughout this chain.
Kedrion has four production sites: two in Italy (Bolognana, Lucca and Sant’Antimo, Naples); one in Hungary (Gödöllő, Budapest) and one in the United States (Melville, NY).
We obtain plasma in a number of ways. In the United States we have our own collection centers and all the products we sell here are derived only from plasma collected in this country. We also own plasma donation centers in Germany and Hungary. In Italy donors donate plasma through the National Health Service in cooperation with donor associations.
Plasma has many components that must be separated in order to produce the therapeutic products useful for many debilitating, often rare, conditions. The process of isolating these components is called fractionation. It was first developed during World War II to isolate albumin from plasma for the treatment of shock. The method was known as the Cohn process after the scientist who developed it and it was responsible for saving thousands of lives on the battlefield. Later research and development allowed for the isolation of other plasma “fractions” – the proteins that are the basis of plasma-derived therapies. Fractionation is in many ways like the refining process for crude oil: the raw material (plasma or crude) is separated into a variety of useful constituents (e.g., albumin and coagulation factors from plasma; gasoline and kerosene from oil) by treating it with various chemicals, environmental conditions and filters.
Kedrion has fractionation facilities in the United States, Hungary and Italy.
Once the various components of plasma are isolated, they are further processed to provide therapeutic products for a number of different disorders such as hemophilia and auto-immune diseases. This work is done in state-of-the-art facilities under Kedrion quality control meeting or exceeding the highest US and international standards. The final products are packaged under strict regulation and safety and made ready for distribution. Kedrion has manufacturing facilities in Italy and Hungary as well as in the US.
The number of people needing plasma-derived therapies is substantial and exceeds the current capacity of the industry to supply them. It is nevertheless still necessary for patients and the healthcare professionals who treat them to know what products are available. The task of the marketing department is therefore informational to make potential buyers aware of our products and to differentiate them from other available choices.
Distribution of plasma-derived products is not a simple matter. They must be packaged, packed and shipped under strict control and monitored environmental conditions. Kedrion demands and provides extensive training for these procedures and shares its expertise with partnering systems to ensure the proper handling and safety of its products delivered under contract.
RESEARCH AND DEVELOPMENT
All along the path from plasma donor to product recipient the processes of research and development are at work. From pre-clinical and clinical research into new therapies to the constant effort to improve the efficiencies in the production of existing products, every effort is made to ultimately help the people who need plasma-derived products. A Global Quality Assurance program works continuously to ensure the quality and safety of products, aided in part by information generated under Pharmacovigilance protocols.
Orphan Drug Development. Some rare diseases are often referred to as "orphan" diseases because they tend not to be “adopted” for attention by pharmaceutical companies. The cost of research and development simply cannot be justified by potential sales. This term is defined differently in different countries, but many countries have developed policies that encourage efforts to develop drugs (“orphan drugs”) for these conditions. Kedrion considers the effort to address orphan disease both a challenge and an opportunity. The financial challenge is balanced by the opportunity to actualize our ideals, to encourage interaction between the worlds of research and business and to inspire a global vision. With the support of Toscana Life Sciences and the Region of Tuscany, Kedrion has established a laboratory for research into plasma-derived orphan drugs.