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The GEM-DIMER™ platform is a proprietary technology developed by Hinge Bio. This technology allows the production of antibodies with enhanced multivalency and multispecificity, enabling the simultaneous targeting of multiple disease-associated antigens. As a result, it has the potential to deliver significantly better therapeutic outcomes. The platform also supports cooperative binding to disease targets, leading to markedly higher biological activity compared to traditional approaches. Additionally, it enables the development of molecules with novel functionalities, offering improved safety and efficacy profiles.
Building on this foundation, the GEM-DIMER™ platform is designed to create therapeutics that deliver better treatment outcomes for patients living with autoimmune, inflammatory, and infectious diseases, as well as cancer. Its ability to produce molecules with entirely new functionalities ensures superior safety and efficacy, setting it apart from conventional technologies.
To address the suboptimal cell growth observed while replicating the client’s feeding regime, new feeding strategies were explored. These experiments aimed to create conditions that supported robust cell proliferation and high protein production. In parallel, oxygen transfer within the bioreactor was carefully fine-tuned to maintain adequate dissolved oxygen levels, which are crucial for efficient expression of the desired protein. The purification process presented significant challenges due to the large size and multivalent nature of the monoclonal antibodies, which our downstream team effectively handled.
An optimal combination of media, feeding strategy, and feeding percentage and temperature shift criteria are critical parameters for maximizing yield. To achieve this, a Design of Experiments (DOE) approach was employed, which resulted in the selection of the most promising experimental conditions. Subsequently, the feeding and aeration strategies were further refined to achieve the desired level of cell productivity. Purification strategy was optimized to achieve greater than 98% purity of drug substance.
The Syngene team forged a highly productive and collaborative relationship with its Hinge Bio counterparts, progressing the project at unprecedented speed, and completing a complex molecule project in seven months. This partnership yielded a three-fold increase in output, an impressive 98.5% total purity, and an overall recovery rate exceeding 50%.
