Clinical Manufacturing
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Since the founding of Sirnaomics in 2007, we have maintained an internal Chemistry Manufacturing and Controls (CMC) team. Our CMC capabilities include delivery platform research, development and optimization, formulation development, and analytical sciences. Our analytical science team implements a science-driven, phase-appropriate, commercially oriented approach using both classic and state-of-the-art analytical techniques and tools throughout the development life cycle of each of our product candidates. This includes, but is not limited to, development and validation of analytical methods for drug substance and drug product, technical transfer of process and analytical methods, establishment of specifications, testing and releasing of each batch of drug product, and quality control and assurance. With a well-documented and comprehensive quality system, the quality control and assurance team are responsible for testing and verifying the product quality with predefined standards to assure the quality of all the batches at every stage of clinical manufacturing and processing.

We currently work with qualified contract manufacturing organizations (CMOs) to manufacture APIs/excipients and product candidates for preclinical and clinical supply. We select our CMOs by reviewing their qualifications, relevant expertise, production capacity and product quality. 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. We have adopted procedures to ensure that the production qualifications, facilities and processes of our CMOs comply with the relevant regulatory requirements and our internal guidelines.

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. Our Guangzhou facility will be capable of GMP-compliant clinical manufacturing of our pipeline products, including formulation, fill and finish, test and release and will be sufficient to support our clinical trials in China, and potentially to supply our clinical trials globally in the future.

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