Zelluna names MaSTherCell as CDMO to support immunotherapy development

The biotechnology company Zelluna, which specializes in TCR-based immunotherapies for solid tumors, has appointed MaSTherCell as its contract development and manufacturing (CDMO) partner.

The partnership is a milestone for Zelluna as it pursues clinical trials and commercialization of its TCR-T multiple targets program, according to the company. Zelluna expects to begin trials in 2019.

“The objective of the collaboration with MaSTherCell is to enhance the GMP manufacturing process and deliver an optimized industrial manufacturing process that can deliver Zelluna TCR-T products for clinical development and eventually commercial distribution, with a broad geographic footprint,”​ Miguel Forte, CEO, Zelluna, told us.

MaSTherCell will initially perform a diagnostic assessment of the existing Zelluna GMP manufacturing process at the facilities at Oslo University Hospital. It will then develop a process development plan to further optimize and automate the current manufacturing process, Forte explained.

“Applying a quality by design (QbD) approach, we know that our development effort will not only fast-track the development of Zelluna’s products, but also prepare the latter clinical phases (III and IV),”​ said Denis Bedoret, managing director, MaSTherCell, who told us the company has worked well with Zelluna in the past.

Bedoret said the next step is to finalize the development plan and to select technologies. “We are today evaluating the equipment candidates for the trials,”​ he explained. “Then the development operations will start with the first runs.”​

Choosing a CDMO​

In selecting a CDMO with which to partner, Forte said relevant experience and know-how, capacity, and cultural fit are key to the assessment.

“From Zelluna’s point of view, MaSTherCell presented an extensive experience in process development and manufacturing of T cell based therapies including engineered TCR targeted T cell products,” ​he explained, adding that Zelluna expects a “fruitful​” collaboration with MaSTherCell.

Forte said it was also important that current and future manufacturing capacity would able to support short-term manufacturing of clinical supplies and potentially medium to long-term commercial supplies. 

Bedoret added that MaSTherCell has “a unique client-oriented business model based on transparency,” ​and believes that this was a key decision criterion.