Flexible multiproduct facility for monoclonal antibodies delivered on fast-track schedule.

A complex project establishing a highly flexible multiproduct system for up-and downstream processing of monoclonal antibodies demonstrates ZETA’s comprehensive abilities. Excellent cooperation and close communication between the customer and ZETA were key to the project’s success and enabled a fast-track and high-quality project delivery.

The customer, a leading international biopharmaceutical company, set an ambitious objective: to establish a cutting-edge manufacturing facility for the in-house production of various monoclonal antibodies using CHO (Chinese Hamster Ovary) cell cultures.
Previously, the production of these therapeutics had been outsourced. At the time of the project’s initiation, some products were still in development, while others were anticipated in the pipeline. To accommodate this dynamic portfolio, the facility required a highly flexible, multi-product system capable of adapting to evolving production needs.

To overcome the deteriorated flooring issue, ZETA proposed a fast-curing polyurethane screed that became fully load-bearing within just two days – saving over ten weeks compared to traditional drying times. This quick thinking ensured the project remained on schedule. Additionally, ZETA implemented a flexible, 24/7 work schedule.

ZETA took on front-to-end responsibility for upstream, harvesting and downstream processing. The division of the project into three sub-projects facilitated its organization. However, the core team remained the same throughout the delivery of all project packages.

ZETA provided maximum flexibility for multi-product use. The process can be adapted for undefined future products. The upstream process can later be doubled in size and scope, and the downstream processing capacity is sufficient to accommodate this type of expansion.

ZETA supplied three autonomous units, each consisting of a 10,000-liter bioreactor and a feed vessel. This allows preparation, fed batch bioprocessing and subsequent cleaning (CIP) to run in parallel.

From filtration, separation of solid cell components, chromatography, virus inactivation and virus filtration to ultra- and diafiltration: ZETA process engineers overcame the challenges posed by the high complexity of the various technical specifications and delivered skids for seven downstream process steps.