By Vivienne Raper, PhD
Good partnership working is essential for combination therapy companies who intend to use contract development and manufacturing organizations (CDMO). That’s according to Robert Farra, CTO at Intergalactic Therapeutics.
The company’s gene therapies deliver a covalently-closed and circular DNA (C3DNA) into the eye using a subretinal injector, avoiding the need to use a virus for delivery.
As their therapy involves both a medical device and a gene therapy, Intergalactic is working with a team of CDMOs.
“I think some could be considered as development partners more than CDMOs while others are truly providing CMO services,” explains Farra. “If you look on the DNA side, we’re traditional in the type of CDMO we’ve selected. But, on the device side, we’re reached out to what we call a development partner who’s helping us do the design and engineering.”
The subretinal injection system consists of a subretinal injection cannula, a low-voltage pulse generator and a single-use electrode to transfect the gene therapy into patient cells. The aim of the injection system, according to the company, is to precisely target body tissues and reduce the risk of an immune response.
Understanding both technologies
The key to successful CDMO partnerships where medical devices and biological components are involved is that company staff need to understand both, notes Farra.
“There are differences in the mindset and development approach, but the team internally needs to understand the requirements and meld together,” he says.
“Once they’re comfortable developing [both components] together, they can share with CDMO partners.”
Talented technical staff needs to work closely with the CDMO on advanced design and detailing work, including daily contact and weekly meetings.
“There’s a lot of communication back and forth and, once a problem is identified, it’s a very collaborative real-time development effort,” continues Farra.
Every team needs to work transparently and openly, he says, including sharing clinical data and information on prototypes. Also, for the collaboration to be successful, the CDMO and company need to be focused on scaling up to high-volume production—both of the medical device and biological component.