‘Viral vector production demand will ultimately exceed the current global capacity’

23-Sep-2020 - Last updated on 11-Jan-2022 at 15:16 GMT

Catalent recently announced that it is investing US$130m in an expansion project at its viral vector manufacturing facility located in Harmans, Maryland, with five new manufacturing suites set to respond to a growing customer pipeline and market demand.

Describing itself as a full-service partner for adeno-associated virus (AAV) and lentiviral vectors, along with CAR-T immunotherapies, the company says it has multi-year experience in viral vector scale-up and production, producing clinical and commercial batches of viral vectors for multiple programs.

Upon completion in the first half of 2022, it says its gene therapy campus in Harmans will house multiple cGMP manufacturing suites with pre-seed, bioreactor, and downstream rooms alongside fill/finish, testing, warehousing, supply chain, and central services capabilities.

“Catalent has several late-stage gene therapy partners with growing capacity needs. The new suites will allow us to have both dedicated and spot capacity for these programs and give us the ability to be a scale-up partner for fast-track programs as they accelerate through the clinic,” explained Colleen Floreck, senior director, global marketing and strategy, Catalent cell and gene therapy.

‘Securing manufacturing space early is critical’

Talking to this publication about how viral vector manufacturing capacity is overstretched by the rapid proliferation of gene therapies, and how Covid-19 vaccine production is exacerbating the situation, she outlined some strategies manufacturers can adopt to deal with such challenges:

“The market for cell and gene therapies has seen double-digit compound annual growth at 22% for the last three to five years. It is expected that this growth will continue to as far out as the future horizon of most market assessments we’ve seen. With so many products fast tracked across various indications, and upcoming approvals anticipated too, viral vector production demand will ultimately exceed the current global capacity.

“It is ever more critical for innovators to secure manufacturing space early, and investors that back such innovators want to see that therapeutic companies have a manufacturing plan early in their pipeline. By securing space with an outsource partner like Catalent, innovators know that suite capacity and manufacturing expertise will continue to grow to meet market demand.

“External development and manufacturing partners are better suited for taking on the risk of building capacity and have the expertise to help customers develop efficient processes that are suitable for their virus type.”

Catalent is working on over 50 Covid-19 related antiviral, vaccine, diagnostic and treatment programs across its biologics, gene therapy, oral technologies, soft-gel and clinical supply businesses.

Late last month, it reported that it was to provide drug substance manufacturing to AstraZeneca for the University of Oxford’s adenovirus vector-based COVID-19 vaccine, AZD1222. The CDMO is also partnering with J&J and Moderna on their lead vaccine candidates.

“With several viral vector vaccines in the Covid-19 pipeline, open viral manufacturing capacity has been in even more demand.

“Catalent has been able to accommodate Covid-19 viral vector programs in the near term to address this global need. At the moment, this is not affecting our ability to continue with our gene therapy programs. As the landscape continues to evolve, we will assess additional expansion possibilities,” said Floreck.

AAV scale-up across multiple platforms

Following a successful FDA inspection at the commercial facility in Harmans, which the company announced in August, she said Catalent is even better suited for swift tech transfer, development and production.

“Catalent’s specialized expertise in AAV scale-up across multiple platforms while simultaneously managing the financial burden, supply chain complexity and process efficiency, create a secure environment for our customers’ products,” she told us.

The team, continued Floreck, has built a solid understanding of the regulatory requirements and management of the time-sensitivity associated with processing, storage and transportation of organic materials.

“These are critical to the success of an advanced therapeutic. Supply chain complexity is another inherent challenge that requires experience and makes standardization of manufacturing difficult.”