Fujifilm Continues The Fight Against COVID-19 With More Vaccine Progress

Started manufacturing at Texas base following North Carolina base
Promote mass production of candidate drug substances for new coronavirus infection vaccines at two bases in the United States
Started mass production preparations at the UK base
FUJIFILM Diosynth Biotechnologies (FDB), a contract development and manufacturing company for biopharmacy (CDMO) * 1 , has joined FUJIFILM Co., Ltd. (President: Kenji Sukeno) , following its base in North Carolina, USA. We are pleased to announce that we have begun manufacturing the drug substance for the new coronavirus infection (COVID-19) vaccine candidate at our base in Texas, USA. Currently, FDB is mass-producing the drug substance of the COVID-19 vaccine candidate at two bases in the United States.

In addition, we are accelerating efforts toward the rapid and stable supply of the COVID-19 vaccine candidate, such as starting mass production preparations for the drug substance of the COVID-19 vaccine candidate at our base in the United Kingdom.

FDB is under development by US biotechnology company Novavax, Inc. , and is one of the COVID-19 vaccine candidates supported by the public-private partnership project “Operation Warp Speed” * 2 launched by the US government. “NVX-” We are entrusted with the manufacture of APIs for “CoV2373”. At the North Carolina base in the United States, mass production of the drug substance of “NVX-CoV2373” started in July 2020 using a 2,000L cell culture tank, and a visit was conducted by former US President Trump at the same time.

With the support of the US government, FDB has completed the installation of nine 2,000L cell culture tanks, which it has been promoting at its base in Texas, USA, and has started the drug substance production of “NVX-CoV2373”. Going forward, we will contribute to the prompt and stable supply of COVID-19 vaccine candidates in the United States through a mass production system at two bases, one in North Carolina in the United States and one in Texas in the United States.

In addition, on February 13, 2021 (UK time), British Prime Minister Boris Johnson visited the UK base, which is preparing for mass production of the drug substance of “NVX-CoV2373”. In the future, FDB will manufacture the drug substance of “NVX-CoV2373” procured by the UK government at the UK base using the production process technology transferred from the North Carolina base in the United States and the 2,000L cell culture tank.

“NVX-CoV2373” is a COVID-19 vaccine candidate that uses a part of the antigen protein created based on the genetic information of the new coronavirus. Novabax began late-stage clinical phase II trials in South Africa in August 2020 and clinical phase III trials in the United Kingdom in September of the same year. In January 2021, we announced that we achieved the primary endpoint and demonstrated efficacy as an interim analysis result of each study. In North America, we are conducting Phase III clinical trials in the United States and Mexico.

FDB has more than 30 years of contract experience, advanced production technology and the latest equipment, and in addition to developing the production process of all kinds of biopharmacy such as hormone preparations, antibody drugs, gene therapeutic drugs, vaccines, etc., from small quantity production to mass production We are entrusted with the manufacture of APIs for COVID-19 vaccine / therapeutic drug candidates by taking advantage of our strength in manufacturing from API manufacturing to formulation / packaging. In the contract of COVID-19 therapeutic drug candidates , mass production of drug substances for antibody drugs of Eli Lilly and Company in the United States , which the COVID-19 treatment promotion project “COVID-19 Therapeutics Accelerator” * 3 supports development and manufacturing It is scheduled to start in April 2021 at the Danish base.

In the future, we will cooperate in the development and manufacture of COVID-19 vaccines and therapeutic agents by utilizing the manufacturing infrastructure of FDB’s bases in Texas, North Carolina, the United Kingdom, and Denmark.

FUJIFILM believes that the fact that the government leaders visited the manufacturing bases in the United Kingdom as well as in the United States shows that the supply of COVID-19 vaccine is a socially important issue. In the future, as development and manufacturing of not only COVID-19 vaccines but also therapeutic agents progress, we will promptly and globally supply high-quality biopharmacy that meets customer needs, prevent the spread of COVID-19 infection, and prevent epidemics. I will contribute to the end.

* 1 Abbreviation for Contract Development & Manufacturing Organization. We provide a wide range of services to pharmaceutical companies, from cell line development in the early stages of drug development to production process development, stability testing, investigational drug development / manufacturing, and over-the-counter drug manufacturing.
* 2 A public-private partnership project launched by the US government with the aim of developing COVID-19 vaccines and therapeutic agents on a rapid and large scale, and is subsidizing multiple pharmaceutical companies.
* 3 A COVID-19 treatment promotion project launched by the Bill & Melinda Gates Foundation with the Wellcome Foundation and Mastercard. This project supports the rapid development and manufacture of therapeutic agents and vaccines for COVID-19.

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