Adjuvants are important ingredients in some vaccines to enhance specific immune responses in recipients and improve vaccination effectiveness in long-term protection. ITRI has assisted the commercial genome sequencing company Genomics in completing a nucleic acid synthesis plant in Taiwan, covering the current gap for local production of nucleic acid vaccine adjuvants. The plant is also able to supply materials for nucleic acid drugs and thus presents opportunities for cooperation with global pharmaceutical firms.
Genomics’ nucleic acid synthesis plant is expected to upgrade the production capability of Taiwan’s drug and vaccine industries.
“ITRI has substantial experience in assisting manufacturers in building GMP compliant factories. This involves R&D, prototype translation, trial production, pre-clinical verification, clinical trials, GMP system implementation, and guidance on bringing products to the market,” said ITRI Executive Vice President Alex Y.M. Peng, who observed that the continued spread of COVID-19 has resulted in the surging demand for adjuvants in vaccine production.
ITRI and Genomics signed an agreement in October 2021 to engage a three-stage cooperation: (1) assistance in overall design and planning of a GMP plant; (2) establishment of quality control standardization in the adjuvant manufacturing process; (3) guidance on obtaining ISO certification. These efforts aim to strengthen the nucleic acid synthesis industrial chain for the independent production of vaccines in Taiwan, while the completion of the plant will also help Genomics tap into the contract development and manufacturing organization (CDMO) market.
Recent trends are underscoring the value of building a nucleic acid synthesis plant. Market research company Mordor Intelligence reported that the global vaccine adjuvant market in 2020 was worth about US$660 million and is poised to hit US$1.47 billion by 2026, with a compound annual growth rate of 13.37%. Factors accounting for the growth include unmet demand for specific vaccines, increasing government vaccination recommendations, technological advances, and the rising use of combined and synthetic vaccines.
Nucleic acid drugs that have potential applications in precision medicine such as gene therapies and immunotherapies are also a focus point in global drug development, and thus a nucleic acid synthesis plant will play a crucial part in the entry to this market. The Genomics facility expects to apply for ISO certification and formally commence production in the fourth quarter of 2022.