CDMO, CMO, Supplier Roundup in Supporting COVID-19 Projects
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Evonik, Fujifilm Diosynth Biotechnologies, and Kaneka.
Biologics Manufacturing
Fujifilm To Produce Antigen for Novavax’s COVID-19 Vaccine
Fujifilm Diosynth Biotechnologies, a biologics CDMO, has been contracted by Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, to produce antigen for up to 180 million doses of Novavax’s COVID-19 vaccine at its site in Billingham, Teesside, UK.
Novavax initiated Phase III clinical trial in the UK in September 2020. In January 2021, the company reported interim results that showed NVX-CoV2373, it’s COVID-19 vaccine, met its primary endpoint in an UK Phase III trial with a vaccine efficacy of 89.3% in preventing coronavirus as well as efficacy against new UK variant.
Fujifilm Diosynth Biotechnologies is also manufacturing the antigen component of the Novavax vaccine candidate at its facilities in North Carolina and Texas.
Source: Fujifilm Diosynth Biotechnologies
Kaneka To Open New mRNA Mfg Facility for COVID-19 Vaccines
Kaneka Eurogentec, an affiliate of Kaneka Corporation, a Tokyo-headquartered chemical manufacturer, has received GMP accreditation by the Belgian Ministry of Health to open a new facility for manufacturing messenger RNA (mRNA) for COVID-19 vaccines.
The new facility will allow the production and the purification of up to the 10-g scale (up to 1 million doses of vaccine) of RNA for use in human clinical trials and commercial supply, with potential for expansion.
The company sys two customers have already signed for three mRNA sequences, including for early phase COVID-19 clinical trials.
Source: Kaneka Eurogentec
Formulation Development/Drug-Product Manufacturing
Evonik To Expand Lipid Mfg for Pfizer’s/BioNTech’s COVID-19 Vaccine
Evonik, a specialty and fine chemicals producer, is expanding its specialty lipids production for mRNA-based COVID-19 vaccines.
Commercial lipid quantities are to be produced at Evonik’s Hanau and Dossenheim sites in Germany as early as the second half of 2021 as part of a strategic partnership with BioNTech, a Mainz, Germany-based immunotherapy company, which is partnered with Pfizer for a COVID-19 vaccine. Evonik has been involved in various mRNA-based vaccines projects for COVID-19. In mRNA-based vaccines, the mRNA is enclosed in a lipid nanoparticle that is comprised of specific lipids.
The COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the marketing authorization holder in the European Union, and the holder of emergency use authorizations or equivalent in the US, the UK, Canada, and other countries in advance of a planned application for full marketing authorizations in these countries.
Source: Evonik
