Since the founding of Sirnaomics in 2007, we have maintained an internal Chemistry Manufacturing and Controls (CMC) team. Our CMC capabilities include the following functions:
- delivery platform research, development and optimization;
- formulation development;
- analytical sciences; and
- quality control and assurance.
We currently work with qualified contract manufacturing organizations (CMOs) to manufacture APIs/excipients and product candidates for preclinical and clinical supply. We have established GMP-compliant manufacturing processes in the U.S. with CMOs accredited by the USFDA and with an annual capacity of approximately two million vials per year.
In 2021, we completed the construction of our pilot plant clinical manufacturing facility in Guangzhou with an annual production capacity of 50,000 vials of lyophilized doses for injection, which we expect to be sufficient to support all currently planned clinical trials. During 2022, eleven batches of drug products were produced at this facility to support our preclinical tox studies and early stage of clinical studies