ImmVira has inaugurated a pilot-scale production line in Shenzhen, China and initiated its in-house production of next-generation oncolytic viruses (OV) used for IND applications and Phase I/II clinical trials. Leveraging a strategy of dual in-house manufacturing and CDMO operations, ImmVira says it can continue to innovate CMC techniques while concurrently improving production efficiency with the goal of expediting the advancement of clinical trials for its pipelines.
 
The company said the launch of the pilot-scale production line demonstrates ImmVira’s capability and focus on CMC development for the purposes of high-yield and low-cost scale production of clinical products. The pilot-scale production line encompasses comprehensive functionalities from cell culturing, virus replication, harvesting, purification, and filling and stoppering—all fully supporting early-stage clinical trials of ImmVira’s next-generation product candidates.
 
At the same time, ImmVira has upgraded its R&D center, designed for both “viral vector” and “non-viral vector”, with newly introduced facilities catering to the R&D and CMC requirements of exosomes development, laying the foundation for pipeline expansions beyond viral vectors.
 
With its OvPENS platform, ImmVira says it continues to make new breakthroughs with its pipeline candidates, as well as CMC, manufacturing and clinical development.
 
ImmVira’s pilot-scale production facility is designed and constructed according to cGMP standards. This facility uses the highest sanitation standards to ensure product sterility and safety. This production line is expected to provide sufficient product supply for Phase I/II clinical trials of several key new pipelines, thus enhancing clinical trial progress and novel candidates development.
 
ImmVira will continue to cooperate closely with Obio Technology (Shanghai) Corp., Ltd. on clinical trials production for its lead products including MVR-T3011 (also known as T3011). In the meantime, the construction of commercial-scale production base is also under active preparation, aiming to have supply chain readiness as candidates across the pipelines reach commercialization.
 
This launch of pilot-scale production facility is an important milestone for ImmVira and a major extension of OvPENS platform to support end-to-end development of novel oncolytic virotherapies.