Prestige Biologics Obtains Patent for Alita Hybrid Production System

[Asia Economy Reporter Ji-hwan Park] Prestige Biologics, a contract development and manufacturing organization (CDMO) specializing in biopharmaceuticals, announced on the 28th that it has obtained a domestic patent for a hybrid system for the culturing and purification processes used in antibody drug manufacturing.

This patent pertains to a hybrid system that combines 'Stainless Steel (SS)' and 'Single Use (SU)' production equipment used in the antibody drug manufacturing process. The official name is ALITA Smart BioFactoryTM. The ALITA system has also completed an international patent application (PCT) for overseas patent acquisition.

The ALITA system is designed to enable independent operation of the 'culturing unit,' classified as an upstream process within the manufacturing suite, and the 'purification unit,' a downstream process, allowing various combinations of manufacturing suites to be operated flexibly according to production processes.

In the contract manufacturing business of biopharmaceuticals, flexibility is required to meet diverse customer needs, including multi-product production and frequent product changeovers. The widely used SS process system had issues such as difficulty in replacing bioreactors, forcing production capacity to conform to pre-installed equipment. While the purification process capacity should scale up with the culturing process, purification columns generally have limited sizes. This bottleneck in the purification process made it difficult to respond flexibly to customer demands.

Prestige Biologics’ newly patented ALITA hybrid system leverages the advantages of both SS and SU systems simultaneously and prevents cross-contamination through independent operation of the culturing and purification units. It is designed to prevent bottlenecks in the purification process through flexible linkage between the culturing and purification units.

Currently, Prestige Biologics is constructing its Osong 2nd Campus applying this ALITA hybrid production system. Upon completion, the facility will be equipped with a state-of-the-art large-scale production capacity totaling 234,000 liters. Along with this patent acquisition, the company expects to strengthen its competitiveness in the biopharmaceutical contract manufacturing market through an innovative CDMO business model that combines the recently acquired EU-GMP certification and contract engineering (CEO) services.

Yang Jae-young, CEO of Prestige Biologics, stated, “The ALITA Smart BioFactory patent clearly demonstrates our outstanding manufacturing facilities and engineering capabilities. We plan to complete the acquisition of three related patents currently filed and solidify our position in the global CDMO market by meeting diverse customer needs with differentiated systems and business models.”

This content was produced with the assistance of AI translation services.