What are the Activities of ADRAGOS PHARMA?

Gaël LE SAUX : We are a CDMO (Contract Development Manufacturing Organization), a pharmaceutical industry subcontractor specializing in the manufacturing and packaging of medicinal products. At our Livron site (Drôme), we focus on two key areas: the production of sterile glass injectable ampoules and the manufacturing of suppositories. Our client base comprises approximately fifty entities, spanning a broad spectrum of therapeutic activities including cardiology, anesthesia, neurology, and numerous others.

Why engage VÊPRES?

GLS : As part of our development and ADRAGOS PHARMA's strategic objectives, we required a new production line for ampoule filling, specifically including a new preparation area for solutions. Given the increasing demand in our sector, we had a critical need for increased capacity. Currently, our production volumes stand at 30 million suppositories and 125 million ampoules, figures projected to grow further in the coming years. Regarding ampoule production, this expansion will establish us as a significant player in the industry.

What Equipment Has Been Installed?

GLS : This was a comprehensive project spanning nearly 600 m², distributed over two levels, and incorporating all grades (A, B, C, and D) of the pharmaceutical reference framework, namely Good Manufacturing Practices. We have a level dedicated to preparation, featuring manufacturing and storage tanks, and another floor with multiple workshops (washer, oven, etc.), along with all the specific elements of a pharmaceutical production line (airlocks, pass-throughs, corridors, etc.). This Cleanroom setup, including its infrastructure and equipment, is a resounding success. Furthermore, VÊPRES executed it under challenging conditions.

What were the constraints of this project?

GLS : I believe the primary challenge was the site itself. Dating back to 1918, it presented architectural, structural, and spatial constraints. VÊPRES rose to the challenge. They adapted to the existing conditions, despite a highly restricted storage and construction environment. Intervention on the site's structure was necessary (complete renovation of the shell and slab, raising the roof on the upper floor) to accommodate the Cleanroom. Subsequently, they carried out the work concurrently with our ongoing operations, which did not cease throughout the year-long construction period. VÊPRES expertly managed the project's complexity.

What are the Regulatory Requirements?

GLS : The pharmaceutical sector is rapidly evolving in terms of regulations, particularly regarding quality standards for sterile drug manufacturing, with constraints on machinery, environment, and practices, notably guided by Annex 1 of the GMP (Good Manufacturing Practices), which has introduced new requirements, leading to regulatory changes in production and environmental controls.

Why did you choose VÊPRES?

GLS : VÊPRES was selected based on positive feedback from Excelvision (FAREVA) and the quality of discussions during the tender process. Their reputation, communication, and level of commitment were key factors.

What are your key takeaways from this operation?

GLS : I commend the dedicated and high-caliber teams and individuals, with whom communication is exceptionally fluid. They are responsive and demonstrate excellent listening skills. This is particularly valuable when undertaking significant, long-term projects.