CDMOs are vital conduits between CGT technology developers and potential adopters, says CPHI panel

The aim of the virtual CPHI Festival of Pharma Cell and Gene Technology roundtable, sponsored by Catalent Pharma Solutions, was to evaluate the myriad new technologies and process platforms in the field and how best to optimise processes and efficiencies.

Shirley O'Dea, Chief Scientific Officer, at Avectas – which is currently developing a non-viral delivery technology that enables delivery of molecules into cells for engineering purposes – said her company had reached the point of being able to transfer tech out and described CDMOs as “key players who help us expose out technology to the wider sector.”

“CDMOs see all the technologies at various stages of development, they see the tech transfer and onboarding processes, and they have highly experienced operators who can give feedback to the likes of ourselves as developers and help us improve our products and our technologies,” she said. “It’s also an opportunity to get an independent view on the technology, to potentially allow partners, through a three-way interaction between the developer, the CDMO and the therapy manufacturer, to work together.”

Thomas VanCott, Global Head of Product Development, Cell & Gene Therapy, Catalent said one of the big challenges for CDMOS operating in the cell and gene sector was the exponential growth of the field and the consequent requirement to work with several unique products and technologies simultaneously.

“Everybody’s coming in with a novel construct, some of these have never been manufactured or been in the clinic before, so it is a bit of a challenge because you’re working with a new product all the time,” he said. “As a CDMO, we’re learning every day from the clients – they’ve been developing these technologies for years. Manufacturing capacity is struggling to meet demand because of the growth, therefore we need to be incorporating all of the latest technologies, and we need to make sure that we optimise our processes and efficiencies.”

He added that CDMOs were also having to quickly adapt to decreasing clinical development timelines, such as the fast-track process for orphan drugs, but despite this were still looking at the various opportunities to innovate within the cell and gene space.

“In viral vectors, we’re trying to be more specific about tissue targeting, we want to be able to do direct dosing, we’d like to be able to carry in larger payloads, and all of these come at it with unique constructs which will require a unique manufacturing platform,” he said.

“The number of technologies and different processes that a CDMO sees give it a unique perspective,” said Jeff Liter, President & CEO of Luminary Therapeutics. “Even if you aren’t using a CDMO, and you have the opportunity to know somebody, that’s a great way to gain some insights into what’s working and not working in this field.”