ReiThera will begin commercial production in 2026, a milestone the CDMO says is key for long-term success.

Contract development and manufacturing organization (CDMO) ReiThera spun out from Okairos in 2013 when GSK acquired the vaccine platform developer for €250 million ($296 million). Since then, the firm has built capabilities for advanced therapies and vaccines at its site in Rome, Italy.

These include its GRAd (gorilla adenovirus)-based vaccine technology, a proprietary Modified Vaccinia Ankara (MVA) vector-based platform, and an adeno-associated virus (AAV) system that uses a transfection-free production method.

ReiThera has also invested in its capacity, with a 1,500 square-meter facility offering commercial GMP viral vector production up to 3,000 liters expected to come online in 2026.

The plant, which is equipped with single-use suspension bioreactors up to the 2,000 L scale, was commissioned in May 2020. It received operational authorization from the Italian Medicines Agency (AIFA) in 2022 with an expectation of supporting the production of ReiThera’s COVID-19 vaccine GRAd-COV2.

GRAd-COV2, which was developed with funding from the Italian government and European Commission, achieved positive Phase II results with peak immune response levels comparable to AstraZeneca’s chimpanzee adenovirus-based vaccine ChAdOx1and Johnson & Johnson’s adeno virus type-26-based HAdV-26 vaccine.

However, GRAd-COV2 suffered setbacks, including public funding issues and a failure to reach the market within the critical window. Development was effectively rendered obsolete by the unprecedented speed of the global market – GRAd-COV2 vaccine was still in late-stage clinical trials in early 2022 while the AZ and J&J vaccines, along with Pfizer and Moderna’s two mRNA-based vaccines, had already been approved and billions of doses administered.

The shift in the COVID vaccine market placed ReiThera in “a precarious position,” according to CEO Stefano Colloca, who spoke about the firm’s response during a press day at ReiThera’s site in Rome in September.

“Fortunately, we managed to increase our client portfolio and overcome the difficulties,” he said, adding the effort and energy of the aborted COVID-program is finally set to pay off through the introduction of commercial production.

The facility is now expected to be in operation in 2026 (“we are in discussion with two clients that will go in commercial phase in the next year.”) This will “project ReiThera into another dimension,” according to Colloca, making it a truly end-to-end CDMO able to offer programs support from discovery through commercialization.

Requirements for a third-party partner have changed in the past 20 years, he explained, due to a volatile biotech market and turbulent funding environment. Biotech investors are “more picky, more selective.”

Previously efficacy data was good enough to attract financial support. Now equity and capital firms want to see a clear plan from Phase I to commercial, including surety of production throughout a product’s lifespan Colloca said, adding “Even if they haven’t started Phase I, they want to be sure that you can support commercial phase.”

Thus, being able to support commercial production is a must, Colloca said. “We have lost clients because we don’t have [commercial] experience, even though we did excellent work with them to support Phase I. They decide to go with other CDMOs with experience in the commercial phase, because this is a requirement from investors.”

Meanwhile, he continued, having commercial capabilities makes life easier for a CDMO as well. “If you work only with clinical stage companies, you are dealing with very volatile businesses because these companies in general don’t have any product on the market, and therefore they rely on funds provided by investors or by grants.”

This volatility means clinical stage firms may put programs on hold, then restart them, then reallocate funds, he said, so for a CDMO “it is very difficult to manage the business. Commercial production is much more predictable because you know how many lots you need to produce and release during a year.”

Making the commercial facility operational, therefore, is critical for ReiThera’s growth strategy but according to Colloca this will be coupled with increasing the CDMO’s client portfolio and the number of technologies it is equipped to work with. “I would also like to enter into the field of RNA production,” he said. “In comparison to fermentation, infection with viral vector purification, process residuals, etc, RNA production is relatively a quite simple process.”