Efforts to develop a vaccine against SARS-CoV2, the virus that causes COVID-19, are accelerating. Pfizer1 recently started testing its vaccine candidate, joining Moderna Therapeutics2 and Oxford University3 on the list of developers that have begun trials. In China, CanSino Biologics has been cleared to start a study of a recombinant SARS-CoV-2 vaccine.4
Vaccine developers have also started to plan how to make their vaccines. Moderna, for example, has partnered with Swiss CDMO Lonza.5 Meanwhile, AstraZeneca has signed up as manufacturing partner for Oxford University’s candidate.
Demand for vaccine manufacturing capabilities and services is increasing across the wider industry too, according to Ashleigh Wake, business development director for pharmaceutical services at Intertek.
“With the urgency to develop a viable vaccine we are seeing a rise in demand for complex molecule characterization and quality control solutions that are vital to driving these products from conceptualization to market,” she tells GEN.
Vaccine manufacture is a difficult process under the best circumstances. For companies rapidly working on SARS-CoV-2, the challenge is even harder, notes Wake, who said effective quality control requires advanced analytical technologies.
“Setting up a QC system to meet GMP regulations, which would be pivotal to a vaccine manufacture, is no small undertaking and in normal circumstances would take months, if not longer, to establish and validate,” she explains. “Any QC system will need to establish control of product, service, or process, overseen by a quality assurance department. Every element of production from monitoring supply chains to cleaning vessels, product characterization and quality control testing will require written procedure following validated approaches.”
The need for specialist manufacturing and monitoring systems is changing how vaccine developers are working with CDMOs during the pandemic.
“Clients are engaging in a larger way with contract development, analytical, and manufacturing services as a way to deliver expertise and capacity immediately, rather than developing it in-house over months or even years,” explains Wake. “Building these large teams of outsourcing and consulting partnerships provides a flexible, agile solution for rapid product development and manufacture.”
Formulation is another focus for SARS-CoV-2 vaccine developers. Points out Mark Parry, technical director at Intertek Melbourn.
“There has been significant focus on options for nasal delivery of vaccines, as these products provide significant advantages for product stability and needle-free wide scale distribution and administration, as well as potential pharmacological benefits in promoting a local mucosal response alongside a traditional systemic response,” he says.
1. Pfizer Starts U.S. Trials of Experimental Covid-19 Vaccine.
2. Moderna Announces First Participant Dosed in NIH-led Phase 1 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus.
3. Oxford COVID-19 vaccine begins human trial stage.
4. Race for a Coronavirus Vaccine.
5. Moderna and Lonza Announce Worldwide Strategic Collaboration to Manufacture Moderna’s Vaccine (mRNA-1273) Against Novel Coronavirus.