SHENZHEN, China, July 19, 2021 /PRNewswire/ — On July 18, 2021, ImmVira inaugurated a pilot-scale production line in Shenzhen and officially initiated its in-house production of our 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, ImmVira can continue to innovate on CMC techniques while concurrently improve production efficiency with the aim to expedite the advancement of clinical trials for its pipelines.
The kick-off of our pilot-scale production line demonstrates ImmVira’s unique capability and focus on CMC development beyond typical pipeline R&D, for the purposes of high-yield and low-cost scale production of clinical products and creating potentially more commercially competitive drug candidates. Pilot-scale production line encompasses comprehensive functionalities from cell culturing, virus replication, harvest, purification to filling and stoppering, fully supporting early-stage clinical trials of ImmVira’s next-generation product candidates. At the same time, the upgraded R&D center is designed for both "viral vector" and "non-viral vector", with newly introduced facilities catering for the R&D and CMC requirements of exosomes development, laying the foundation for pipeline expansions beyond viral vectors.
Looking beyond the mission to lead innovation and develop first-in-class therapies and leveraging the OvPENS platform, ImmVira continues to make new breakthroughs with its pipeline candidates, as well as CMC, manufacturing and clinical development. This end-to-end development model not only enhances the advancement of our clinical trials, but also acts as the driving force for ImmVira to sustain the lead position in future large-scale manufacturing and commercialization. ImmVira’s pilot-scale production facility is designed and constructed according to cGMP standard. 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. ImmVira will stay committed to providing effective, innovative and safe anti-cancer oncolytic virotherapies.
ImmVira is a biotechnology company focused on genetically modified oncolytic viruses as potential cancer therapeutics. The company has developed science, technology and know-how to support ongoing research, development and commercialization of oncolytic viruses on the OvPENS (OV+ Potent, Enabling, Novel & Safe) platform. The OvPENS platform comprises of research, patents, gene-recombinant know-how, manufacturing technology and commercialization analytics to develop next-generation oncolytic viruses that reach drug development targets and that are potent, enabling, novel and safe.
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