#USA #gene therapy #Morrisville #Biologics #Solvias

Solvias Opens a State-of-the-Art Center for Biologics and Gene Therapy

Morrisville, North Carolina — January 27, 2025
In a significant move for the biopharmaceutical industry, Solvias, a leading global provider of chemistry, manufacturing, and control (CMC) analytics, has inaugurated its new Center of Excellence for biologics and cell and gene therapy in the dynamic Research Triangle Park (RTP) region. This facility marks a new chapter in Solvias's expansion strategy, aimed at enhancing the development of transformative therapies for cancer and rare diseases.

A Cutting-Edge Facility

The state-of-the-art 50,000-square-foot laboratory serves as Solvias's flagship site in North America, dedicated to the analytics of large molecules. By offering comprehensive services specifically designed to accelerate the market entry of groundbreaking biologics, this center will play a pivotal role in the global drug development landscape.

As part of its establishment, the facility is anticipated to create approximately 200 new jobs in the Raleigh-Durham area within the next three years, directly contributing to the local economy.

Phased Development Approach

The opening of the center follows a phased development approach:

• - Phase 1 includes a 20,000-square-foot section dedicated to Good Manufacturing Practice (GMP) compliant release testing. This will involve potency assays, molecular-based cell tests, and is set to be operational immediately.
• - Phase 2 will expand the facility with an additional 30,000 square feet slated for completion by July 2025. This phase will bolster capabilities in stability testing and advanced biophysical characterization.

Advanced Capabilities

Equipped with cutting-edge analytical instruments and state-of-the-art automation technology, the new facility will offer comprehensive GMP testing services for cell and gene therapies, monoclonal antibodies, and other biologics from preclinical stages through to commercialization. The sophisticated digital management systems in place ensure high-quality and reliable analytical support, meeting the rigorous standards required in the life sciences sector.

Commitment to Innovation and Patient Care

Archie Cullen, CEO of Solvias, expressed his enthusiasm about the new facility, highlighting its importance in the company's global growth trajectory. "This center is a significant milestone in our commitment to providing robust analytical support that meets the needs of our clients and accelerates the delivery of innovative therapies to patients worldwide."

Ilya Koltover, Commercial Director at Solvias, emphasized the firm's commitment to facilitating success for its clients through analytical expertise. "We are eager to recruit top-tier talent to serve as technical partners for our customers, helping them to bring therapies to market more quickly and efficiently. This investment solidifies our role in the U.S. biopharmaceutical innovation ecosystem."

Expanding Global Presence

With this launch, Solvias expands its global footprint to a total of six centers of excellence, marking the second site in North America. The company is dedicated to maintaining the highest industry standards, ensuring that all facilities adhere to stringent ISO, GMP, GLP, and FDA guidelines.

For more detailed insights about Solvias’s new center of excellence and its services, visit solvias.com.

About Solvias

Founded near Basel, Switzerland, Solvias is committed to providing end-to-end solutions for the life sciences industry, encompassing everything from raw material testing to pharmaceutical product release and active ingredient development for small molecules. Their expert team combines decades of experience with regulatory expertise in small molecules, biologics, and cell and gene therapies.

For press inquiries, please contact:
Stephen Smith
General Manager, USA
Email: [email protected]
Phone: +1 (919) 389-0377