With a pair of production facilities already on deck, a new contract development and manufacturing organization has surfaced in Europe.
Based in Poland, biologics-focused Rezon Bio announced its launch on the European manufacturing scene Monday. The company plans to use its biosimilars know-how to make development and commercialization processes simple and straightforward for partners.
The company boasts Polish production sites in Gdańsk and in the Warsaw-Duchnice area. It's capable of handling projects from cell line development all the way through manufacturing and commercial supply, Rezon said in a Sept. 29 press release.
The sites feature “mirrored capabilities,” which Rezon expects to make technology transfer and scale-up activities simpler for clients. The sites leverage single-use manufacturing systems in a bid to accelerate product turnover as well as advanced micro-scale bioreactor systems designed to shorten early development cycles and make expansion activities less risky.
The Gdańsk site spans 7,500 square meters (around 80,729 square feet) and carries out R&D activities alongside manufacturing, Rezon says on its website. The site is equipped to develop drug product formulations and can also handle clinical and medium-scale commercial production runs.
Rezon describes the Warsaw facility as “one of Europe’s largest and newest,” noting online that the plant serves as its commercial-scale production facility. The site also features drug substance quality control labs, according to the CDMO.
Both facilities have been vetted by the U.S. FDA and the European Medicines Agency, Rezon said.
“Rezon Bio is a new name, but it stands on a track record that already includes building a broad biosimilars portfolio—with two products launched worldwide through our partners,” Adriana Kiędzierska-Mencfeld, Rezon’s new CEO, said in the company’s launch announcement.
“That experience is the foundation of our new CDMO offering,” she continued. “We know the challenges of developing and launching biologics because we have been through them ourselves. Now we are here to make that journey easier, faster and cost-efficient for our clients.”
Aside from the facilities themselves, Rezon is also implementing process modeling, artificial intelligence and “project transparency tools” to help keep customers informed during the development and manufacturing processes.
The company will handle drug substance development and manufacturing in-house while relying on external partners to carry out drug product activities.
Multiple European CDMOs have sought to expand their presence in the bloc this year, including Greece’s Famar, which inked a deal to acquire a German sterile manufacturing facility in May. Meanwhile, German CDMO BioSpring in July said it was building what it hopes will become one of the world’s largest manufacturing sites for DNA- and RNA-based active pharmaceutical ingredients.
And, in April, another fledgling CDMO emerged in Europe in Meribel Pharma Solutions. The contractor, which will be based in the U.K., was formed after the company’s financial backer—U.S. private equity firm Blue Wolf Capital—acquired a string of Recipharm production sites and bought out French contract manufacturer Synerlab.
Meribel is pitching itself as a midsized CDMO with a strong background in oral solids, semisolids and sterile drugs.