The Besançon center of the French Blood Establishment (EFS) is part of the national EFS network, a public institution responsible for ensuring self-sufficiency in labile blood products and guaranteeing their quality and safety. It encompasses activities including collection, biological qualification, preparation, and distribution of blood products intended for healthcare facilities in the Bourgogne–Franche-
Comté region.
Among these activities, the preparation and freezing of plasma bags constitute a key step in the process of valorizing blood donations. The Besançon center is equipped with dedicated devices for the rapid freezing of Fresh Frozen Plasma (FFP), in compliance with current regulatory requirements and quality standards.
The majority of plasma bags are used for the production of medicines by the Laboratoire Français du Fractionnement et des Biotechnologies (LFB), whose main mission is to produce and distribute medicaments derived from human plasma, intended to treat severe and rare diseases.
The need for plasma for drug production is such that supply from the French EFS alone is not sufficient. In a report published in 2024, the LFB indicated it used 1.3 million liters of plasma for its annual production, of which 900,000 liters came from France. LFB aims to increase the available plasma to 3.4 million liters per year to support increased fractionation capacity.
Self-sufficiency in plasma-derived medicinal products (PDMPs) is a major strategic issue for the French government, often described as a matter of health sovereignty.
All these elements show that the need for plasma is therefore very high. It is within this context that the EFS in Besançon acquired a new FROILABO blast freezer. This application note describes the reasons behind the choice of this equipment, the procedures for freezing plasma bags, the critical parameters of the process, as well as the control points ensuring product quality and traceability.