30 OCT. 2024
The Arras site, a state-of-the-art industrial plant
This new generation plant, which will begin operations by the end of the year, will enable LFB to triple its bioproduction capacities for immunoglobulins, albumin and fibrinogen.
A plant with gravity-driven flow
The gravity-driven concept of the Arras plant, designed to facilitate flows and improve yields, is at the cutting edge of technology for the production of medicinal products.
The production building boasts 3 production levels, each dedicated to a series of specific operations. Production will begin at the top level, at a height of 30 metres, with the thawing of plasma bags and the preparation of solutions to be used for the manufacture of the medicinal products. The second level is where the plasma will be purified in specific workshops for transformation into medicinal products. The ground floor is dedicated to filling of vials and freeze-drying of the medicinal products.
Three distinct production units
One of the specific features of the Arras plant is to have 3 specific production lines on each production floor, each dedicated to the purification and safety steps for each medicinal product separately: immunoglobulins, albumin and fibrinogen.
This organisational structure is designed to avoid cross-contamination between the products.
The Arras plant in brief :
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X 3for production capacity
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A fully-automated plant
MES: Manufacturing Execution System
LFB has opted to adopt the MES management system, a comprehensive software solution allowing for the management of production as a whole. The MES is integrated into LFB’s existing computer system and will allow the operators to track, monitor and control the entire production process from the starting material to the finished product.
What the system offers:
– Improved quality control with the real-time transmission of information, and the possibility to halt production if a problem is identified,
– Creation of an optimised production schedule with centralised scheduling of teams, materials and equipment,
– Up-to-date inventories of stock levels in real time,
– No more use of paper documents,
– Improved production flows, in compliance with regulations.
Automated pharmaceutical formulation
Each and every pharmaceutical formulation step performed on LFB’s medicinal products will now be automated. This will guarantee aseptic conditions and therefore maximise the safety of the final medicinal products, particularly during filling into vials, which is an at-risk step.
Filling lines under isolators: The plant is equipped with 3 filling lines, all under isolators. Each line is used only for one medicinal product:
– There are 2 lines for liquid products, albumin and immunoglobulins,
– The third line is dedicated to fibrinogen, and includes freeze dryers.
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3filling lines
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4possible vial formats per line
New generation freeze dryers:
With the Arras plant, LFB opted for freeze dryers that automatically adapt to each freeze-drying cycle of a given product. This design sets a new standard that will serve as a reference for future LFB freeze dryers.
The new freeze dryer models are equipped with automatic vial loading and unloading systems that meet current quality standards.
