Solvias CoE for Biologics & Novel Modalities Becomes cGMP Ready

Solvias, a global provider of chemistry, manufacturing, and controls (CMC) analysis, has announced that its recently opened Center of Excellence for biologics and novel modalities in Research Triangle Park (RTP), North Carolina, is now Current Good Manufacturing Practice (cGMP) ready.

This milestone enables the RTP facility to deliver fully compliant analytical testing and release services for advanced therapies from early-stage development through commercialization.

Archie Cullen, CEO of Solvias, said, “We are delighted with the progress of our facility development in the U.S. It has been a real testament to the hard work and commitment from our teams in both the U.S. and Europe. We have also been truly fortunate to have so many U.S.-based customers supporting us in shaping the design and ensuring the right capabilities are developed. We look forward to the next few months with our core focus on supporting our customers and the incredible new therapies they are bringing to market.”

Solvias’ European labs have a track record of supporting developers of advanced modalities across the full product lifecycle. Now, with the RTP site achieving cGMP readiness, the company is extending this expertise to meet the growing demand for specialized analytical services in the U.S. To further support this growth, Solvias also announced that the site’s Phase 2 build-out, which will add an additional 30,000 square feet of advanced laboratory space, is set to open this month.

This expansion will strengthen analytical capabilities for a wide range of modalities and delivery systems, including adeno-associated virus (AAV), mRNA, monoclonal antibodies, recombinant proteins, antibody-drug conjugates (ADCs), cell therapies, peptides, and oligonucleotides.

Amale von Planta, Chief Strategy Officer at Solvias, said, “This site is more than just additional space—it is a strategic asset designed to meet the evolving challenges of modern drug development. With expanded modality support and integrated service packages, we are enabling smarter, more agile outsourcing decisions for our clients across the industry.”