Demand for viral vectors was already high pre-pandemic, with an increasing number of gene and cell therapies. Now recombinant vector COVID-19 vaccines – such as AstraZeneca and Johnson & Johnson’s vaccines – have put a second and more immediate stress on the viral vector supply chain.
If it is to meet the near-future need for viral vectors, the industry will need several billion liters of annual bioreactor capacity. This capacity simply does not exist at the moment – in fact, it’s currently at less than 1% of what will be required, according to analysis from data, analytics and insights firm GlobalData.
Why is demand so high?
There are currently 14 gene therapies, gene-modified cell therapies, and recombinant vector vaccines approved and marketed in the EU, Japan, US and UK, according to figures from GlobalData. But this is set to rise dramatically.
“We predict that this number will soar in the near future. We anticipate that over 100 more gene therapies and gene-modified cell therapies will be approved over approximately the next six years. These therapies will all need viral vectors and will exacerbate the manufacturing shortage,” notes GlobalData in its 2021 report The Outlook for Viral Vector Contract Manufacturing.
Added to that is the demand from vaccines. Over the last year, the emergence of viral vector vaccines has increased pressure on viral vector supply: creating a sizeable and more pressing demand. Following the development of viral vector vaccines from AstraZeneca, Sputnik V and Johnson & Johnson, more are in the pipeline for COVID-19 alone: with 55 vaccines of this type under evaluation, according to the WHO's tracker.
And the tech could be in demand outside of COVID-19 vaccines: with the University of Oxford recently starting Phase 1 trials for a new vaccine against plague, based on the COVID-19 vaccine's ChAdOx1 adenovirus viral vector platform.
In total, there are more than 3,000 gene therapies, gene-modified cell therapies, and recombinant vector vaccines in the development pipeline.
Yet against this future demand, a shortage of viral vectors exists due to insufficient manufacturing capacity, an inefficient manufacturing process, and the requirement for complex specialist facilities.
So what can be done to tackle the shortage?
Viral vector development and production is often outsourced: and so CMOs could have a key role to play in meeting demand. There are currently only 87 viral vector contract manufacturing facilities worldwide: and these facilities are spread out thinly among many companies (few companies own more than two viral vector facilities).
Scaling up capacity and investing in new facilities is one way to start to address the shortage: with top CMOs now investing in more sites. . Last year, for example, Catalent announced a $130m investment in an expansion project at its viral vector manufacturing facility in Harmans, Maryland: with five new manufacturing suites set to respond to growing demand once completed next year.
Other M&A and partnerships are helping build capacity and capabilities in the space: with a wave of activity in recent months. In May, Charles River acquired US based CDMO Vigene Biosciences for its CGMP viral vector manufacturing expertise. Belgium’s Univercells Technologies and China’s VectorBuilder, meanwhile, entered into a strategic global partnership for custom viral vector production in July. In January, Thermo Fisher Scientific bought Henogen – Novasep’s viral vector manufacturing business in Belgium - to extend its capabilities in cell and gene therapies and vaccines.
A second solution is to develop more efficient processes for viral vector manufacturing: with GlobalData noting that “improvements in both upstream and downstream virus production are anticipated in the near future”.
As an example, the UK last month announced three new gene therapy innovation and manufacturing hubs: which will not only manufacture clinical grade adeno-associated viruses but also be ready to investigate ways to 'radically increase yields and reduce productivity barriers in future years'.
And thirdly, regulatory changes would help ease the viral vector bottleneck. “If agencies approve standardized viral platforms that could be used interchangeably by therapy developers, this would speed up development, approval, and technology transfer to CMOs,” notes GlobalData.