Sartorius Stedim Biotech marks 25 years of M’Hamdia operations in Tunisia

TUNISIA — Sartorius Stedim Biotech is marking 25 years of operations at its M’Hamdia site in Tunisia, highlighting the facility’s expansion into a major assembly hub for single-use biopharmaceutical manufacturing solutions.

The M’Hamdia facility was established in 2001 and began production in 2002 under the Stedim Group.

Following the formation of Sartorius Stedim Biotech in 2007, the site became part of the company’s global manufacturing network, supplying biopharmaceutical customers in international markets.

The facility focuses on single-use technologies, including bags used to manufacture biologic medicines, vaccines, and cell and gene therapies.

These systems can support pharmaceutical manufacturers by reducing the cleaning and sterilization required for conventional reusable equipment.

Since its establishment, Sartorius Stedim Biotech has expanded the site through investments in infrastructure, production capacity, and employee training.

The company launched the Sartorius Tunisian Academy in 2020 to develop skills for advanced cleanroom operations.

A major expansion completed in 2021 further increased the facility’s production capacity.

Today, the site covers approximately 20,000 square metres, including 4,500 square metres of production space and 4,000 square metres of cleanroom facilities.

It operates three cleanrooms and 36 assembly lines, producing products including Biosafe, Flexsafe, and Flexel 3D.

Between 2021 and 2025, Sartorius Stedim Biotech invested more than €21 million (US$24.7 million) in the facility.

The site now employs more than 800 people, more than twice the number employed at the beginning of the decade, with women accounting for half of its workforce.

Focus on quality and sustainability

The company has also expanded its focus beyond production capacity, with the facility maintaining certifications related to energy management and sustainable manufacturing.

These include ISO 50001 for energy management and ISCC PLUS for sustainability.

The site has received several national recognitions from Tunisian institutions and public agencies for occupational health and safety, employee development, social progress, innovation, and technology transfer.

These include the National Occupational Health and Safety Award and the KAFAET certification for employee training and workforce development.

“Over the past 25 years, M’Hamdia has become a key part of our manufacturing network, enabling us to deliver reliable, high-quality single-use solutions to customers around the world,” said René Fáber, CEO of Sartorius Stedim Biotech.

“With the biopharmaceutical industry expected to continue its growth trajectory, our M’Hamdia site is well positioned to contribute to bringing innovative therapies to more patients globally,” he added.

Supporting biopharmaceutical production

The company said the anniversary also recognizes the contribution of employees and local stakeholders to the facility’s development.

“This 25th anniversary is above all a celebration of the people who have shaped M’Hamdia over the years,” said Abderrahim Ben Fraj, Head of Operations at Sartorius Stedim Biotech’s M’Hamdia site.

“Their commitment and expertise have made the facility what it is today: a trusted partner for our customers. We look forward to continuing this journey together and contributing to the development of the life science sector for many years to come,” he added.

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