Clean Cells launches activities at new biopharmaceutical quality control facility – largest in Europe

With 5,300m² of new premises, €22M building offers four times more laboratory space than previous facility

Company anticipates strong growth in demand and activity, focusing on new treatments such as cell and gene therapies, and offering new and improved services, including Next-Generation Sequencing (NGS) and karyotyping

Montaigu-Vendée, near Nantes, France, March 1, 2023 – Clean Cells, part of the Clean Biologics group, a provider of biopharmaceutical product quality control services and manufacturer of starting materials, today announces the launch of analytical activities at its new facility, based in Montaigu-Vendée. With an investment of €22 million ($24.1M), €5.5 million ($5.81M) of which is for new equipment, the site offers four times more laboratory space than the previous building. Covering a total of 5,300m² (57,000ft²), including 2,800m² (30,100ft²) of laboratories, it is the largest biopharmaceutical testing site in Europe.

This is a major milestone for the company. Customers will have access to the same fast response from the Clean Cells teams, now with additional high-quality equipment, including a state-of-the-art monitoring system, providing better pharmaceutical organization. The new bespoke building will enable the company to develop its activities in innovative sectors, such as gene therapy, with the implementation of new tests in its catalogue to meet the needs of the market. It will also allow the company to offer new and improved innovative platforms, including Next-Generation Sequencing (NGS) and karyotyping.

“We’re very proud to have started our activities in these new facilities, as planned. This project is the culmination of five years of planning, design and construction to support the company’s growth in response to market demands. The Clean Cells teams have managed the transfer outstandingly well, allowing us to continue to work on our customers’ projects with the highest standards while setting up additional innovative platforms,” said Joseph Jammal, CEO of the Clean Biologics group.

The global biologics safety testing market was estimated to be worth $3.6 billion in 2022 and should reach $6.8 billion in 2027. This represents growth at a CAGR of 13.3%; driven by the expanding development of biologics and biosimilars, growing concerns over cell culture contamination and rising biopharmaceutical R&D investments.

This new laboratory space provides Clean Cells, which has proven expertise in quality control, especially in viral safety and genetic stability, with much greater potential for strong growth. Testing capacities are multiplied by four and cell bank production capacity has doubled, enabling Clean Cells to respond even more swiftly to client requests and accelerate the development of biopharmaceutical drugs. New and improved safety tests will allow the company to actively assist clients through the regulatory process.

“The consistent involvement and high level of competence of our teams has enabled us to seamlessly transfer activities to our new quality control laboratories; ensuring continuity of service for our customers,” said Gwenaël Autret, head of quality control at Clean Cells. “These new laboratories will allow us to accelerate the development of Clean Cells’ services by significantly increasing our biosafety testing, and cytogenetic and potency assay capacities.”

Clean Cells plans to recruit 20 new staff in 2023 to help deliver its new high-quality services.

About Clean Cells

Clean Cells is a subsidiary of Clean Biologics. It offers (i) quality control and biological safety tests for biopharmaceutical products to assist in regulatory compliance, (ii) production of cell banks and GMP-grade BSL2/BSL3 virus seed stock, (iii) supply of secure storage for these products and (iv) development and validation of bespoke analysis tools.

The company was created in 2000, when three biologists from the Aventis–Institut de France Foundation sought to offer innocuity testing for biopharmaceuticals. Clean Cells is now one of the largest European companies within this sector. Its strong customer focus and sizable product catalog (which expands annually) have made it a key player in the development of novel treatments and in personalized medicine. Clean Cells also stands out for its ability to react and adapt to its customers’ needs and the transparency of its production and quality control processes.

Based near Nantes, in Western France, Clean Cells employs 130 staff.

www.clean-cells.com