Solvias, a global provider of chemistry, manufacturing and controls (CMC) analysis, announces that its recently opened Center of Excellence for biologics and novel modalities in Research Triangle Park (RTP) is now current Good Manufacturing Practice (cGMP) ready.
This milestone enables the RTP facility to deliver fully compliant, high-quality analytical testing and release services for advanced therapies from early-stage development through commercialisation.
Archie Cullen, CEO of Solvias, said: "We are delighted with the progress of our facility development in the US. It has been a real testament to the hard work and commitment from our teams in both the US and Europe."
"We have also been truly fortunate to have so many US-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 long-standing, successful 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 specialised analytical services in the US.
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.
"This is a significant milestone achievement for Solvias in our continued expansion into the US testing market for novel therapies and biologics services," said Steve Smith, Chief Operating Officer.
"In roughly one year, the Solvias team went from shell space to an operational laboratory to support our client testing needs for complex therapies."
"In addition, our second phase of the facility expansion will be completed within the month, which will further extend our capabilities to deliver complex analytical packages for a range of modalities."
Amale von Planta, Chief Strategy Officer at Solvias, added: "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."
