Research and Development

TrueBinding specializes in process and formulation development for mAbs. Our comprehensive capabilities include material generation using a selected top pool at a 20L scale, utilizing platform cell culture and purification processes. We produce materials for analytical testing, formulation development, and preliminary toxicity runs.

Our upstream process development focuses on optimizing the cell culture conditions by fine-tuning the feeding strategy and bioreactor cell culture. We conduct three rounds of optimization at 1-3L scale using 12 bioreactors to achieve high titers while maintaining utmost quality. Our purification process development includes three column purification steps, a virus inactivation step, and a nanofiltration step to ensure the isolation and purification of the antibodies.

To verify the robustness of our developed process, we perform two 5L cell culture runs, which not only serve as process verification steps but also contribute to material generation. In addition, we offer formulation development services where we create optimized formulations for the monoclonal antibodies, ensuring stability and compatibility during clinical use. With our expertise and capabilities, we strive to deliver high-quality monoclonal antibodies for therapeutic applications.