To kick off 2025, MabPlex International, Ltd (MabPlex) and Zhejiang Teruisi Pharmaceutical, Inc (Teruisi) are pleased to report the successful execution of three batch productions supporting Process Performance Qualification (PPQ). Execution of the qualification protocol was completed smoothly, accelerating progress in the clinic and bringing commercial release of TRS005 one step closer to actualization.
TRS005 is a novel, proprietary antibody-drug conjugate (ADC) designed for the treatment of CD20+ non-Hodgkin lymphoma (NHL). Current data from the clinic suggests that TRS005 has the potential to outperform competing products, and approval has been granted to initiate pivotal Phase II trials for patients that have relapsed following standard treatments.
The partnership between organizations began at the IND stage, combining Teruisi’s antibody intermediates with MabPlex’s expertise in conjugation and CMC to secure approval for a new ADC and begin in clinical trials. MabPlex has subsequently executed nearly a dozen cGMP batches to supply clinical demand.
In June of 2023, MabPlex submitted the winning bid to partner with Teruisi for late stage development and commercialization, which was formalized in October of the same year. Process transfer was completed without incident and pivotal trials were supplied from a 2000L bioreactor production followed by a 100L conjugation batch.
Within 13 months MabPlex completed analytical method validation, process characterization, and PPQ production, laying a solid foundation for future submission of Teruisi’s Biologics License Application (BLA).
TRS005 is the second ADC process validation executed at MabPlex, and the second of five validations completed at our facilities as of January 2025. Three additional late-stage programs are slated to be completed by year’s end.
Dr. Kai Huang (President of Teruisi) remarked:
“We are elated by the successful completion of the TRS005 PPQ milestone. This accomplishment brings us one big step closer to benefiting patients on a global scale. We are deeply impressed by the MabPlex team and appreciative of their high-quality work and execution under such a challenging timeline.”
From Dr. Xinfang Li (CEO of MabPlex): “Congratulations on the successful PPQ completion for TRS005! It has been an honor to partner with Teruisi and we are grateful for their support and collaboration. Our technical team approached this challenge with efficiency and professionalism, successfully advancing our Client’s program. MabPlex has honed our integrated CMC services relentlessly over the last twelve years, providing reliable execution for innovative technologies across the globe.”
