CDMO, CMO, Supplier Roundup in Supporting COVID-19 ProjectsBy
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Fareva, Almac, Batavia Biosciences, and Halix.
Chemicals/Chemical API Manufacturing
Almac Gets Funding as Part of UK Gov’t’s COVID-19 Recovery Plan
Almac Sciences, part of the Almac Group, a Craigavon, UK-based CDMO, has secured an award from the UK government for a manufacturing project as part of an initiative to fund new products or services to support businesses’ recovery from the COVID-19 pandemic.
The Phase 1 award was granted under the Sustainable Innovation Fund: Small Business Research Initiative (SBRI). The initiative is being led by Innovate UK, part of UK Research and Innovation, the UK national funding agency for science and research, and is an SBRI competition, which is funding organizations to develop and demonstrate new products or services to help businesses and/or the public sector in the UK recover from the coronavirus pandemic in a sustainable manner.
Professor Tom Moody, Vice Technology Development and Commercialization, Almac Sciences, and Arran Chemical Company (Ireland), will lead a team of experts to complete the project entitled, “Manufacturing Oxidative Products” over the next three months. The funding received from the SBRI will enable the team to demonstrate both flow chemistry and biocatalytic routes to oxidative products as a technology platform for the UK fine chemical and pharmaceutical industries.
The findings of the project will then be submitted to Phase 2 of the Sustainable Innovation Fund and, if successful, could receive additional funding of up to £3 million ($4 million) over a one-year period to continue research, development and testing.
Last month (November 2020), Almac announced it has been awarded a grant of approximately $500,000 by the COVID-19 Therapeutics Accelerator, a philanthropic collaboration, for the production of Gilead Sciences’ remdesivir.
Source: Almac Group
Halix, AstraZeneca in Mfg Pact for COVID-19 Vaccine
Halix BV, a Leiden, Netherlands-based biologics CDMO, has signed an agreement with AstraZeneca for the large-scale commercial drug-substance manufacture of AZD1222, AstraZeneca’s adenovirus vector-based COVID-19 vaccine.
Under the agreement, Halix will provide commercial manufacturing of the drug substance at its facility in Leiden, The Netherlands, where the company has expanded with two additional viral vector production lines.
With this agreement, Halix continues its role as one of the original partners in the University of Oxford’s consortium for the manufacture of AZD1222. The vaccine was co-invented by the University of Oxford and its spin-out company, Vaccitech, and licensed to AstraZeneca.
Batavia Biosciences, KU Leuven in Pact for COVID-19 Vaccine
Batavia Biosciences, a Leiden, the Netherlands-based CDMO, and KU Leuven, a Leuven, Belgium-based research institution, have entered in a partnership to develop a vector-based COVID-19 vaccine candidate.
Under the partnership, Batavia will develop a clinical manufacturing process for the vaccine candidate, deliver clinical product, and prepare for large-scale commercial supply. The partnership aims to deliver the clinical product and to commence clinical testing in 2021.
The virology team at the KU Leuven Rega Institute for Medical Research developed a SARS-CoV-2 vaccine candidate consisting of an attenuated vector carrying the SARS-CoV-2 spike immunogen. The vector is derived from the live-attenuated yellow fever vaccine.
Source: Batavia Biosciences
Formulation Development/Drug-Product Manufacturing
Fareva, CureVac in Pact for Fill/Finish Mfg of COVID-19 Vaccine
Fareva and CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics, have entered into an agreement regarding the fill–finish manufacturing of CureVac’s COVID-19 vaccine candidate, CVnCoV, at Fareva’s sites in Pau and Val-de-Reuil, France.
Under the agreement, Fareva will provide the production capacity for filling vials with the vaccine and the diluent at its sites in Pau, France and Val-de-Reuil, France to support the production of millions of doses of CVnCoV. The mRNA vaccine will be supplied to Fareva by CureVac. CureVac is building an integrated European vaccine manufacturing network with several CDMO partners. With this strategy, the company says it will increase manufacturing capacity to develop up to several hundred million doses of its vaccines per year.
Fareva’s Val-de-Reuil-site has more than 500 employees and is dedicated to the manufacturing of sterile active pharmaceutical ingredients (APIs) and sterile finished dosage forms (e.g., lyophilized vials, prefilled syringes and ampoules). The site in Pau, France is a more recent acquisition by Fareva from Pierre Fabre Group, and has more than 250 employees. It is dedicated to the sterile fill–finish manufacturing of biologics and high potent APIs, including freeze-dried products.