GERMANY – US-based pharmaceutical company, Catalent has started construction of a US$20 million expansion project at its clinical supply facility in Schorndorf, Germany.

The project is expected to increase the site’s footprint by 32,000ft² to add capacity for the handling and storage of clinical trial supply materials at controlled room temperatures between 15-25 degrees Celsius.

Expected to be completed by June 2024, the project will create space in the original plant to adjust the commissioning of a new, fully automatic bottle-filling line, and a special area for the firm’s FastChain demand-led supply service.

Catalent clinical development and supply division head and president Ricky Hopson said: “Our site in Schorndorf plays a key strategic role in our global clinical supply network, and this expansion will provide much-needed capacity and capabilities to meet the growing needs of customers.

“Additional temperature-controlled handling, storage, and distribution mean the facility is well-equipped to respond to the growing demand for clinical supply capacity and services in the region, including for products requiring cold chain support.

“Working closely with our adjacent oral dose manufacturing center of excellence, and our European development centers for oral, biologic, cell therapy and gene therapy products, customers have access to fully integrated development, clinical packaging, and distribution solutions.”

Opened in 1996, Catalent’s Schorndorf clinical supply facility provides comprehensive clinical supply services including multi-lingual project services – including English, French and German – comparator sourcing, primary and secondary packaging, labeling, clinical storage and distribution, and returns and destruction.

Catalent’s FastChain demand-led supply service is said to be a continuous Good Manufacturing Practice (GMP) approach.

It disintegrates primary from secondary packaging to generate cost-effective and timely adaptation and regional supply of clinical materials.

In February this year, Catalent finished the previously announced US$2.2 million expansion project of its clinical supply facility in Singapore. The project has resulted in a 20% increase in the floor space of the facility.

The expansion included the addition of specialized secondary packaging capabilities for ULT products, enabling the site’s services to support larger packaging campaigns, and increasing capabilities to handle biopharmaceuticals and advanced modalities, including mRNA-based vaccines, and cell and gene therapies.

In December last year, the company completed the expansion of another clinical supply facility in Shanghai, China.

The expansion increased the facility by approximately 30,000 ft2, which has allowed for the installation of additional refrigerated and deep-frozen storage, as well as the expansion of secondary packaging capabilities.

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