Kedrion’s plasma-derived therapies help people suffering from debilitating conditions like Hemophilia and Immune Deficiencies to live more full and healthy lives. We are privileged to provide this service and do so with a profound sense of responsibility.
Keep life flowing
ABOUT KEDRION BIOPHARMA
Kedrion is a biopharmaceutical company specialized in the development, production and distribution of plasma-derived products, used to treat patients suffering from Hemophilia, Immune Deficiencies, infectious diseases and other serious illnesses, and to prevent hemolytic disease of the newborn.
In Italy, Kedrion is the partner of the National Health Service for the achievement of nationwide self-sufficiency in plasma derivatives. In addition, its expertise serves other strategic partnerships with health institutions in other countries.
Kedrion is based in Italy, has companies in Europe, Mexico and the United States and sells its products in more than 90 countries worldwide. The production is concentrated in the two Italian plants of Bolognana, near Lucca, and Sant’Antimo, near Naples, in the Hungarian facility of Gödöllő, near Budapest, and in the American plant of Melville, in the State of New York. The production facilities are certified according to international GMPs (Good Manufacturing Practices) and based on FDA (Food and Drug Administration) requirements.
Because of its high degree of quality and know-how, Kedrion is also dedicated to technology transfer. The company has the most sophisticated and advanced expertise that enables it to offer its technological know-how in the production of pharmaceuticals and the development of manufacturing plants.
Its wide range of products and its constant commitment to research and development represent the key factors of Kedrion’s success.
EXPERTISE AND TECHNOLOGY TRANSFER
Kedrion is proud to be the partner of the Italian National Healthcare System as it pursues the goal of self-sufficiency in the development and supply of plasma-derived medicinal products. The unique expertise acquired in this public/private partnership has provided Kedrion special opportunities and responsibilities. While Kedrion actively promotes the sale of its plasma-derived products internationally, it is also dedicated to transferring its expertise and technology to healthcare systems around the world, facilitating the establishment of their own self-sufficient plasma collection and fractionation systems.
Kedrion has established a step-wise process for this transfer of expertise and technology:
1. Consultation and assistance in developing local plasma collection centers
2. Provision of fractionation services (toll fractionation) of plasma to produce derivative medicinal products (clotting factors, albumin and immunoglobulin) for return to the partner country
3. Expertise and technology-transfer for establishment of a local plasma processing plant with the eventual goal of performing all phases of production, packaging and marketing within the budget of the partner system. (For this phase in particular Kedrion offers end to end support, from Plant Analysis and Design through Personnel Training to Authorization and Start-up).
BIOLOGICAL SAFETY CENTER
The outcome of Kedrion’s devotion to patients’ health and product quality is the Biological Safety Center BioSC, voted to viruses and prions safety services, which has been up and running at the Italian manufacturing site of Bolognana (Lucca) since 2010. The main goal of BioSC is patients’ safety through its activities and continuous innovation.
Relying on the experience earned by working in biological product safety (mainly plasma-derived products) within Kedrion, BioSC has the expertise required to validate processes that can inactivate/remove any pathogen agents in biological and biotechnological productions.
For Kedrion’s products, the “short-chain” service provided by the Center reduces response time and operational costs. Currently, the Center’s knowledge of manufacturing processes, direct contacts with the plant and the sharing of the corporate goal help reduce timing and, above all, provide a high quality service.
The Center aspires to become a national and international safety landmark for all those who, while keeping patients at the center of their value chain, need to guarantee pathogen safety of their products.
In addition to biological drug manufacturers, the service provided by BioSC is also targeted to manufacturers of pathogen-removing devices, such as filter membranes, nano-filters, UV lamps, disinfectants.
As well as to the industry, this service is also addressed to support scientific and research organizations in their activities.
Product Development at Kedrion encompasses a number of departments and activities that operate along the entire chain from basic research and industrial development to pre-clinical and clinical development through market launch and post marketing surveillance (pharmacovigilance). At all levels our goal is to encourage innovation and to press for continual improvement in all of our processes and products.
Kedrion is constantly seeking to create new products and improve existing ones, and we strive at all times to improve efficiency and capacity at all our sites.
Developing and improving medicinal and pharmacological products requires careful and intense clinical studies, including observational studies. The people working in Clinical Operations plan implement and manage these activities as well as non-clinical projects related to Kedrion products.
It is essential that those involved in marketing and education at Kedrion be well-informed about the medical characteristics of all Kedrion products as well as the disorders they are associated with. It is especially important that they are aware of the regulatory framework surrounding those products. Kedrion is convening advisory boards of medical experts in each of the regulatory jurisdictions in which it operates to establish an interactive communication regarding these matters.
Kedrion supports its external marketing and sales network as well as collaborating healthcare operators with up-to-date scientific information.
There are many diseases and disorders that are life-threatening or chronically debilitating but which affect very few people. Some of these are referred to as neglected or Orphan Diseases because there is little economic incentive to research and develop treatment for them. Drugs that are found or developed to treat these disorders have come to be known as Orphan Drugs.
Because the work at Kedrion is directed at providing to patients relief from rare diseases and disorders, the company takes special interest in the development of Orphan Drugs. This commitment results in several projects, two of which are in an advanced stage of development and these are: Plasminogen Concentrate in the form of eye drops for treating Ligneous Conjunctivitis, an extremely rare condition that can lead to blindness, most often diagnosed in infants and children, and Factor V Concentrate, for treating a rare bleeding disorder resulting from a deficiency of this protein.
Kedrion’s commitment to alleviating the pain and suffering from Orphan Diseases has led to the establishment of a plant in Siena, Italy, the first of its kind in Europe, dedicated to research and development of Orphan Drugs. The laboratories are part of a collaboration among Kedrion, the Regione Toscana and Toscana Life Sciences company.
Ph. Christian Sinibaldi