15:42 PM | January 18, 2021 | Sotirios Frantzanas
Specialty and fine chemical companies are playing a vital role in the race to develop and manufacture vaccines to protect against COVID-19. Many producers of specialty chemicals signed contract-manufacturing deals with pharmaceutical companies for COVID-19 vaccine candidates during 2020. These agreements may evolve into long-term partnerships, with most extending beyond 2021, and more deals are expected to be announced this year.
The messenger ribonucleic acid (mRNA) vaccine developed by Pfizer and BioNTech was the first to be approved for systematic vaccination of the population against COVID-19, initially by the UK and then by the EU and US. Specialty chemical companies Siegfried and Croda International are involved in the production of the Pfizer/BioNTech vaccine.
Siegfried signed a cooperation and supply agreement with BioNTech in September for the large-scale aseptic filling and packaging of commercial quantities of the Pfizer/BioNTech COVID-19 vaccine, BNT162b2. Siegfried will provide filling services for the vaccine at its Hameln, Germany, site from mid-2021, under the terms of the agreement. It says that the first phase of the agreement will end in 2022, with the shared intention to expand the cooperation into a strategic partnership between BioNTech and Siegfried.
Croda announced in November that it had entered into a five-year agreement with Pfizer to supply novel excipients used in the manufacture of the Pfizer/BioNTech COVID-19 vaccine. Croda is supplying four component excipients used in the production of the vaccine for the first three years of the contract. Croda says that “if Pfizer’s publicly indicated vaccine doses for 2021 were to be required, the sales value of Croda’s contract in 2021 could be of the order of $100 million.”
Specialty chemical companies are also involved in producing the COVID-19 vaccine ChAdOx1 nCoV-19 or AZD1222, developed by the university of Oxford, UK, in cooperation with AstraZeneca, and approved currently for use in the UK, India, Argentina, Dominican Republic, El Salvador, Mexico, and Morocco.
Halix (Leiden, Netherlands), a biopharmaceutical contract development and manufacturing organization (CDMO), signed an agreement in December with AstraZeneca to provide large-scale commercial manufacturing of drug substance for AZD1222. Halix is one of the original partners in Oxford University’s consortium for the manufacture of AZD1222, the company says.
“Through the consortium, the partners are bringing their collective expertise and manufacturing capabilities to support vaccine production and combat this evolving crisis,” says Alex Huybens, COO at Halix.
Oxford BioMedica, a company specialized in the development of gene-based medicines; and Cobra Biologics (Keele, UK), a biopharma CDMO, are also participating in the consortium for manufacturing AZD1222. The two companies signed agreements with AstraZeneca in 2020 to provide large-scale manufacturing capacity for AZD1222.
Meanwhile, the UK subsidiary of Wockhardt (Mumbai, India), a pharma and biotechnology company, has entered an agreement with the UK government to provide “fill and finish” services for AZD1222 at Wrexham, UK.
Lonza announced in October that it had signed an agreement with AstraZeneca to manufacture AZD7442, a combination of two long-acting antibodies, for the COVID-19 vaccine, at Lonza’s new facilities at Portsmouth, New Hampshire. AstraZeneca will be one of the first companies to access Lonza’s new mid-scale facilities at Portsmouth, with operations expected to start in the first half of 2021, Lonza says.
Lonza also entered a 10-year collaboration agreement with Moderna in May to enable larger-scale manufacture of Moderna’s mRNA vaccine against COVID-19 and additional Moderna products in the future. Moderna’s vaccine has been approved for use by the US, Israel, Canada, EU, and UK.
Agreements for other COVID-19 vaccine candidates, for which development has not been completed, include Wacker Chemie’s contract with CureVac in November to produce the mRNA drug substance for CureVac’s COVID-19 vaccine candidate CVnCoV and support the production of the CureVac vaccine at Wacker’s Amsterdam, Netherlands, biotech site.
CureVac announced earlier this month that it had entered a collaboration and services agreement with Bayer. Under the terms of the agreement, Bayer will support the further development, supply, and key territory operations of CVnCoV. Bayer says that CureVac achieved a milestone in the development of CVnCoV with the start of its global pivotal Phase 2b/3 in December.
Meanwhile, Kaneka (Tokyo, Japan) says that its affiliate based at Liège, Belgium, Kaneka Eurogentec, has signed an agreement with Inovio Pharmaceuticals to join a worldwide consortium for the large-scale manufacture of plasmid DNA, which is used as the drug substance for Inovio’s COVID-19 vaccine candidate.
Inovio has received clearance from the US FDA to proceed with the Phase 2 segment of the vaccine candidate’s Phase 2/3 clinical trial, which will be supported financially by the US Department of Defense, Kaneka says.
In addition, the Russian ministry of health has approved an amendment to the Phase 3 trial format for the Gamaleya Institute’s (Moscow, Russia) adenoviral-based COVID-19 vaccine Sputnik V, and Sinopharm (Beijing, China) has announced interim results from Phase 3 clinical trials of its inactivated whole-virion COVID-19 vaccine BBIBP-CorV, which reportedly demonstrated a 79.34% efficacy rate, according to IHS Markit.
With vaccination campaigns under way in several countries, IHS Markit says it expects “fully approved, effective vaccines with access to large populations across several countries in mid-2021, enabling the safe reopening of those economies.”
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