Solvias has achieved Current Good Manufacturing Practice (cGMP) readiness at its Research Triangle Park (RTP) center, enabling phase-appropriate analytical testing and release services for advanced biologics and novel modalities.

The upcoming Phase 2 expansion will add 30,000 square feet of lab space, enhancing capabilities across multiple modalities including AAV, mRNA, ADCs, and cell therapies.

Solvias, a global leader in chemistry, manufacturing, and controls (CMC) analysis, has marked a significant milestone with its Research Triangle Park (RTP), North Carolina, facility achieving cGMP readiness. This advancement allows Solvias to provide fully compliant analytical testing and release services spanning early-stage development to commercialization for advanced biologics and novel therapeutic modalities.

Archie Cullen, CEO of Solvias, praised the achievement, highlighting the collaborative effort between the US and European teams and the vital input from US-based customers in shaping the facility’s capabilities.

“We are excited to support our clients and the innovative therapies they are bringing to market.”

Building on a solid track record from its European labs, Solvias is extending its expertise to the US market, meeting rising demand for specialized analytical services. The upcoming Phase 2 expansion, set to open imminently, will add 30,000 square feet of advanced laboratory space, further strengthening the company’s analytical capabilities.

The expanded RTP center will support a diverse range of modalities and delivery systems including adeno-associated virus (AAV), mRNA therapeutics, monoclonal antibodies, recombinant proteins, antibody-drug conjugates (ADCs), cell therapies, peptides, and oligonucleotides.

Steve Smith, chief operating officer, said: “In roughly one year, the RTP facility transformed from shell space into a fully operational laboratory supporting complex therapy testing. The Phase 2 build-out will expand our ability to deliver sophisticated analytical packages across modalities.”

Amale von Planta, chief strategy officer, said that the site is designed as a strategic asset to address evolving drug development challenges. She added: “With enhanced modality support and integrated services, we enable smarter, more agile outsourcing decisions across the industry.”