Solvias Achieves cGMP Readiness at RTP Site, Expands US Analytical Capabilities

  • Solvias’ new facility in North Carolina is now cGMP-ready, enabling compliant analytical testing for biologics and novel therapies.
  • A 30,000-square-foot expansion of the site will open this month, further boosting capacity for complex modalities.

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

This achievement allows the RTP facility to provide fully compliant analytical testing and release services for advanced therapies from early development through to commercialisation. The move significantly strengthens Solvias’ offering in the United States, where demand for specialised analytical support for biologics and complex therapies continues to grow.

The company’s established European laboratories have supported developers across the full product lifecycle. With the RTP site now operational, Solvias brings this expertise to US-based customers, many of whom contributed to shaping the new facility’s design. “We are delighted with the progress of our facility development in the US,” said Archie Cullen, CEO. “We have also been truly fortunate to have so many US-based customers supporting us… ensuring the right capabilities are developed.”

To support continued growth, Solvias confirmed that Phase 2 of the site build-out—adding 30,000 square feet of advanced lab space—will be completed this month. The expansion will enhance analytical capabilities for a wide range of modalities, including AAV, mRNA, monoclonal antibodies, recombinant proteins, ADCs, peptides, oligonucleotides, and cell therapies.

“This is a significant milestone achievement for Solvias in our continued expansion into the US testing market,” said Steve Smith, Chief Operating Officer, citing the team’s rapid progress from shell space to a fully operational lab within a year.

The company described the RTP site as a strategic asset designed to support agile outsourcing decisions for developers navigating the complexity of modern drug pipelines.

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