Solvias Enhances U.S. Operations as RTP Center Achieves cGMP Readiness for Advanced Biologics

Solvias Expands U.S. Operations

In a significant step forward, Solvias, a key player in chemistry, manufacturing, and controls (CMC) analysis, has announced the cGMP readiness of its recently established Center of Excellence located in Research Triangle Park (RTP), North Carolina. This milestone allows the facility to provide fully compliant and high-quality analytical testing and release services that cater to advanced therapies from early development phases to commercialization.

Commitment to Quality and Growth

Archie Cullen, the CEO of Solvias, expressed enthusiasm about the progress made at the RTP facility. He acknowledged the immense effort and dedication shown by the teams in both the U.S. and Europe, stating, "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."

Cullen further highlighted the valuable support from numerous U.S.-based clients, which played a crucial role in shaping the design and development of necessary capabilities at the facility. Looking ahead, Solvias is poised to support its customers and the remarkable new therapies they are working to introduce to the market.

Expanding Capabilities

Solvias' European laboratories have a proven track record in supporting developers through the entire product lifecycle of advanced modalities. With the RTP site achieving cGMP readiness, the company is now expanding its expertise to meet the rising demand for specialized analytical services across the U.S. In line with this growth, Solvias has also announced the upcoming completion of the site's Phase 2 build-out, which will add 30,000 square feet of advanced laboratory space this month.

This expansion is expected to enhance analytical capabilities for a diverse range of modalities and delivery systems. These include adeno-associated viruses (AAV), mRNA, monoclonal antibodies, recombinant proteins, antibody-drug conjugates (ADCs), cell therapies, peptides, and oligonucleotides.

Steve Smith, Chief Operating Officer, emphasized the significance of this cGMP achievement as a vital step in Solvias' ongoing expansion into the U.S. market, particularly in the sector of novel therapies and biologics services. He praised the Solvias team for transforming a previously empty space into a fully operational lab capable of meeting the testing needs for complex therapies within just a year. The second phase of the facility's expansion, which will further augment the company’s capacity to deliver complex analytical packages, is set to be completed within the month.

Strategic Asset in Drug Development

Amale von Planta, Chief Strategy Officer at Solvias, described the RTP site as more than just an expansion of physical space; she views it as a strategic asset designed to address the evolving challenges faced in contemporary drug development. With its enhanced support for various modalities and integrated service offerings, Solvias is facilitating smarter and more agile outsourcing decisions for clients across the pharmaceutical landscape.

About Solvias

Founded 25 years ago, Solvias has positioned itself as a leading provider of CMC analytics in the global life sciences industry. The company's team combines extensive experience with regulatory expertise across various sectors, including small molecules, biologics, and cell and gene therapies. Solvias provides comprehensive solutions from raw material testing to drug product release and API development for small molecules. Its headquarters are situated near Basel, Switzerland, and it operates six global Centers of Excellence that adhere to the highest standards of ISO, cGMP, GLP, and FDA regulations. For further details, please visit solvias.com.