During a recent visit to ReiThera's facilities in Italy, I saw first-hand how the company is leveraging decades of vector expertise, manufacturing capabilities, and a focus on quality to help clients bring gene therapies and vaccines from concept to clinic.
Shutterstock Zeljko Radojko
From spin-out to specialist ReiThera’s story begins with a team of scientists who left Merck Research Laboratories to pursue novel viral vector technologies. Founded in 2013 as a successor to Okairos, the company has built a reputation as a one-stop partner for the development and GMP manufacturing of viral vectors. Over the years, ReiThera has supported programs ranging from Ebola vaccines to HIV and COVID-19, demonstrating both scientific depth and manufacturing agility.
The company’s facility reflects that expertise. With validated suspension production up to 2,000 litres and the flexibility to run smaller, personalised vaccine lots, ReiThera can accommodate projects at every stage. The site’s capabilities include automatic filling for up to 10,000 vials, a dedicated personalised medicine suite for patient-specific lots, and GMP areas configured to handle the unique requirements of different viral vectors, including non-filterable viruses such as MVA.
Lessons from a pandemic The COVID-19 pandemic both challenged and accelerated ReiThera’s growth. The team expanded its facility in record time—adding large-scale bioreactors and rapidly validating processes for Phase II clinical production. “COVID was a challenge,” one senior leader reflected. “We were crucial to Italy’s response but lacked the financial support to complete Phase III. We had to fund much of the effort ourselves, which was risky, but it validated our platform technology.”
While ReiThera’s COVID-19 vaccine never reached market, the experience strengthened its technical foundation and doubled its revenues between 2020 and 2024. The company is now completing the final upgrades needed to support commercial production, with client programs expected to reach that stage in 2026.
CEO Stefano Colloca said: “Commercial readiness is the next big milestone. Clients now expect a clear path from Phase I to commercial launch. Having that capability will transform us from a small player into a much larger CDMO.”
Technology and quality at the core ReiThera’s value lies not only in infrastructure but in its deep process knowledge. The company offers proprietary technologies such as the GRAd adenovirus platform, which has shown strong CD8 T-cell induction, and custom-developed cell lines optimised for high productivity and regulatory compliance. Its quality system meets both European and FDA GMP standards, with regular AIFA inspections and a proven track record of clinical lot release across the EU, UK, US and Africa.
The team’s scientific mindset is evident in their approach to new vectors and manufacturing challenges. From adapting adherent processes to suspension growth to developing cost-saving analytical methods, ReiThera works closely with clients to refine technologies early—reducing risk and accelerating timelines.
“We can start with a client’s existing process and help optimise cell lines, vector design, or scale-up,” explained ReiThera’s process development team. “That early investment pays off downstream, especially when moving toward commercial supply.”
Global logistics and cold chain excellence Advanced therapies require more than scientific expertise—they demand flawless logistics. ReiThera places strong emphasis on safeguarding product integrity through strict cold chain control, specialised packaging, and full traceability. Each international shipment begins with a regulatory assessment of the destination country, ensuring import/export authorisations are secured and documentation prepared in advance. Transport routes and local infrastructure are carefully evaluated to minimise customs delays and deliver products on time. As the logistics team explained: “By addressing these factors upfront, we provide a more reliable and competitive service.”
Looking ahead While Italy remains its manufacturing base, the focus is on achieving commercial readiness and expanding the client portfolio. With its combination of proprietary technology, flexible manufacturing, and proven quality, ReiThera is well positioned to meet the growing demand for advanced therapy manufacturing—and to help the next generation of vaccines and gene therapies reach patients worldwide.