COVID-19：FDB，英国的疫苗和原料药的合同生产：候选疫苗
富士Diosynth Biotech：（FDB）
从2021年初开始，将在英国开始生产。
FUJIFILM的子公司，是生物制药* 1开发和制造的合同制造商（CDMO）。
我们正在承包制造由英国政府采购的COVID-19候选疫苗的原料药。
与英国原料药生产签有合同：
我们这次委托的COVID-19候选疫苗是我们开发的“ NVX-CoV2373”。
从2021年初开始，FDB将在英国基地生产“ NVX-CoV2373”原料药，并将为疫苗的快速和稳定供应做出贡献。
关于“ NVX-CoV2373”：
它是一种候选COVID-19疫苗，它使用根据新冠状病毒的基因信息产生的抗原作为有效成分。
开始III期临床试验：
Novabux计划从今年秋天开始在美国和英国开始“ NVX-CoV2373”的III期临床试验。
英国政府：
2020年8月，决定从Novabux采购6,000万次剂量的“ NVX-CoV2373”。
我们宣布了在英国进行的“ NVX-CoV2373” III期临床试验和生产系统建设的合作。
FUJIFILM [日本]
https://www.fujifilm.com/jp/ja/news/list/5283
BILLINGHAM,
UK,
August 17,2020
FUJIFILM Diosynth Biotechnologies,
a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies,announce today that
its site in Billingham, UK will manufacture antigen component of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. Billingham plans to begin production of the first batch at beginning of Q1, 2021.
Novavax
has signed on August 14 a Heads of Terms (Term Sheet) with the Government of the United Kingdom (UK) for the purchase of 60 million doses of NVX-CoV2373 and a Phase 3 clinical trial to assess the efficacy of the vaccine in the UK population.
The Phase 1 data of the Phase ½ clinical trial has already demonstrated to be generally well-tolerated and to elicit robust antibody responses numerically superior to that seen in human convalescent sera.
FUJIFILM Diosynth Biotechnologies
expands its collaboration with Novavax to its UK site, in addition to its sites in North Carolina and Texas in the U.S., to ensure stable manufacturing supply of Novavax’ COVID-19 vaccine candidate.
FUJIFILM Diosynth Biotechnologies Billingham site
has the capacity to produce up to 180 million doses annually, which further boosts the global supply of NVX-CoV2373 for additional markets. Production at the Billingham site will begin in early 2021.