CMOs are expanding capacity for manufacturing the viral vectors needed to make COVID-19 vaccines, gene therapies, and gene-modified cell therapies, a GlobalData PharmSource report shows. But compared with monoclonal antibody therapies, there are relatively very few viral vector contract manufacturing sites worldwide: 87 facilities, owned by 62 companies in 15 countries, according to The Outlook for Viral Vector Contract Manufacturing: Gene Therapies, Cell Therapies, and COVID-19 Vaccines (May 2020).

A shortage of viral vectors exists due to insufficient manufacturing capacity, an inefficient manufacturing process, and the requirement for complex specialist facilities. This shortage will be worsened by a coming wave of gene therapies and gene-modified cell therapies, and by the enormous number of doses to be manufactured of certain COVID-19 vaccines that require a viral vector (recombinant vector vaccines), notably those made by AstraZeneca’s (Cambridge, UK) Covishield and Johnson & Johnson’s (New Brunswick, NJ) vaccine.

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The majority of the world’s dedicated contract and excess capacity manufacturing facilities capable of viral vector manufacturing are in the US. The US has 45 such sites, compared with 32 across Europe. There are only seven sites in Asia. This contrasts with manufacturing of other molecule types. The majority of small molecule API manufacturing facilities are located in China and India, and Asia has increased its protein and peptide biologics manufacturing in recent years, but it has not yet caught up with other regions when it comes to cell and gene therapy manufacturing.

After the US, the UK has the most viral vector sites. The UK government has funded viral vector manufacturing via Innovate UK and the Industrial Strategy Challenge Fund, including establishing the not-for-profit Cell and Gene Therapy Catapult (London, UK).

A dedicated contract manufacturing model is offered by CMOs that offer only outsourced contract services and are not a Marketing Authorization Holder (MAH) of a drug. An excess capacity manufacturing model is offered by pharmaceutical companies that produce their own products and also offer contract services using their excess production capacity, but are also MAHs. There are far fewer excess capacity viral vector manufacturing facilities than those belonging to dedicated CMOs. This ratio is far more pronounced than that for protein and peptide biologic manufacturing, where excess capacity manufacturing is common. In the case of viral vectors, few pharma companies with their own facilities have the spare capacity to take on external contracts, with notable exceptions: Novartis (Basel, Switzerland) announced in March 2021 that it will close its Zolgensma manufacturing facility in Colorado (see B/POR, March 2021). Furthermore, cell and gene manufacturing, as it currently stands, does not have the same level of interchangeable platforms that monoclonal antibody production uses, meaning that it will be more difficult to manufacture another company’s product. Vasily Medvedev, head of development at the CDMO Exothera (Brussels, Belgium), told us that “many vaccine-producing pharma companies are quite reluctant to invest in their own facilities, which risk becoming redundant once the pandemic recedes.” Producing viral vectors requires an inherently high level of manufacturing expertise and expensive facility requirements. CMOs that have made this high CapEx investment will benefit from this significant opportunity.

Viral vector production requires a biosafety level 2 (BSL2) facility, which has more constraints than the BSL1 facilities used to produce monoclonal antibodies. BSL2 facilities may have the same equipment as for other biologics, but they have greater containment needs so the virus does not escape: for example, there is a difference in pressure between the viral vector production zone and other facility zones, and a retention area in case of leakage. These constraints mean viral vector facilities cost more and take more time to build.

Cell & Gene Therapy Coverage on Pharmaceutical Technology supported by Cytiva.

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