Sandoz is planning a roughly $300 million investment in a new biosimilar drug substance manufacturing facility in Ljubljana, Slovenia, as the company moves to expand its European production footprint and add greater flexibility to its biologics manufacturing network. The planned site is expected to begin operations in 2029 and will introduce disposable fed-batch (DFB) manufacturing capabilities to Sandoz’s existing portfolio of high-volume and continuous production technologies. The company expects the facility to provide approximately 8,000 liters of additional biologic drug substance capacity.

The investment is designed in part to address the manufacturing requirements of lower- and medium-volume products, complementing Sandoz’s existing infrastructure for larger-scale production. Four DFB reactors are planned for the facility, which will be capable of supporting both clinical-stage and commercial manufacturing. According to Sandoz, adding DFB technology will give the company greater control over how manufacturing capacity is allocated across its biosimilar portfolio. The approach is also intended to increase production flexibility as demand evolves across different products and markets.

The new plant will be located alongside Sandoz’s recently opened biosimilar development center in Ljubljana. The proximity of the two facilities is expected to facilitate technology transfers and scale-up activities, while bringing development and manufacturing operations closer together.

Armin Metzger, president of Biosimilar Development, Manufacturing & Supply at Sandoz, said the project will broaden the company’s manufacturing options across different production volumes.

The Ljubljana investment forms part of Sandoz’s broader Bio100 strategy, which the company announced alongside the facility plans. The initiative is aimed at capturing a substantial portion of the long-term opportunity expected from the expanding biosimilars market.

For Sandoz, the additional manufacturing capacity also represents an effort to maintain greater control over its supply chain. By expanding in-house drug substance production in Europe, the company expects to strengthen its ability to manage capacity as its biosimilar portfolio grows.

The project builds on earlier investments Sandoz has announced for its biosimilar development and manufacturing operations in Slovenia. Together, the facilities are intended to support an end-to-end development and supply network spanning clinical development through commercial production.

With construction planned around the new DFB capability and operations targeted for 2029, the Ljubljana project will add another manufacturing platform to Sandoz’s European biosimilar infrastructure at a time when manufacturers are seeking more adaptable approaches to biologics production.

For more information, visit www.sandoz.com.