Adimmune Corporation (4142) announced on the 11th that its second fill & finish line has passed the inspection of Food & Drug Administration (FDA) of Ministry of Health and Welfare (MOHW) in Taiwan for GMP compliance. This new production line is officially launched and the first batch of production is the public tender quadrivalent (QIV) seasonal influenza vaccines of 2021. Adimmune indicated that the full capacity of this new production line can reach up to 80 million doses per year. The company will apply for inspections from EU EMA and US FDA to better align production and CDMO service with global market demand.
The fallout of COVID-19 and border control did not hinder the progress of Adimmune’s second fill & finish line construction. With the help from MOHW, Center of Disease Control, Ministry of Foreign Affairs as well as its embassies and missions, the mechanics and engineers from Germany and Italy were able to come in Taiwan to install the machines as scheduled and conducted test runs of this highly automated production line. After the on-site inspection from the FDA in Taiwan, the new line received GMP certification in early August this year.
Adimmune’s second Taiwan GMP-certified fill & finish line has already started operating to manufacture and to fill & finish the public tender QIV seasonal influenza vaccines. It is estimated that more than 50% of Taiwan’s public tender seasonal influenza vaccines in 2021 is to be manufactured by this new production line.
In addition to the public tender influenza vaccines, the second production line has also been scheduled for validation and certification in order to fulfill several other international orders. Adimmune will continue to apply for inspections from EU EMA and US FDA. After receiving the certifications, it will be used for the CDMO service of over 40 million doses of Techdow’s enoxaparin exported to the European market yearly. Meanwhile, Adimmune has secured the contract with Korean SCD for the CDMO service of macular degeneration solution, both for the clinical trial batch and the commercial production batches. The company is ordering special dedicated instruments and components to create fully aligned manufacturing facility for this product.
Adimmune pointed out that the design capacity of this second automatic fill & finish line can reach 80 million doses per year. The new facility will complement Adimmune’s existing capacities to produce up to 100 million doses per year. Adimmune is on track to further accelerate its global expansion, including international orders for influenza vaccines and fill & finish CDMO service, with the objective of introducing Taiwan-made high-quality vaccines and biologics to the global market.