#USA #gene therapy #Morrisville #Biologics #Solvias

Solvias Launches New Center of Excellence

On January 27, 2025, Solvias, a global leader in chemistry, manufacturing, and control (CMC) analytics, announced the grand opening of its innovative Center of Excellence for Biologics and Cell & Gene Therapy located in Morrisville, North Carolina. This facility marks a significant expansion in Solvias' global network, reinforcing the company's commitment to advancing groundbreaking therapies aimed at cancer and rare diseases.

A Strategic Move in Research Triangle Park

Spanning an impressive 50,000 square feet, the new center stands as Solvias' flagship site in North America for large molecule analytical services. It is poised to expedite the development and commercialization of transformative biologics, while also creating approximately 200 employment opportunities in the Raleigh-Durham area within the next three years. The facility's opening is being executed in two distinct phases:

• - Phase 1: The initial 20,000 square feet has been designed specifically for cGMP (current Good Manufacturing Practice) testing, which includes cell-based potency and molecular assays, and has commenced operations immediately.
• - Phase 2: The remaining 30,000 square feet are set to open in July 2025, expanding the capabilities for stability testing and advanced biophysical characterization.

State-of-the-Art Facilities and Expertise

The center is equipped with cutting-edge analytical instruments, laboratory automation, and sophisticated digital management systems, ensuring comprehensive GMP testing for cell and gene therapies, monoclonal antibodies (mAbs), and other biologics. This comprehensive support spans everything from preclinical stages right through to commercial release, which positions Solvias as a pivotal player in the CMC landscape.

Archie Cullen, the Chief Executive Officer of Solvias, expressed his enthusiasm about the center's strategic importance, saying, "This Center of Excellence in RTP is a milestone in Solvias' global growth journey. By combining our team's expertise with advanced technology, we aim to set a new benchmark for delivering high-quality, reliable analytical support. It's an honor to partner with our clients in delivering groundbreaking therapies to patients around the world."

Ilya Koltover, Chief Commercial Officer of Solvias, added that the firm is focused on empowering its clients through analytical expertise in an efficient manner. "We are hiring the best possible talent to be technical partners for our clients, helping them bring therapies to market faster and more efficiently. This investment showcases our commitment to being a key player in the US biopharma innovation ecosystem."

Expanding Global Footprint

With the launch of this new center, Solvias enlarges its operational presence to six centers of excellence around the globe, compacting its initiatives to serve the biopharma industry effectively. This is only the second facility Solvias operates in North America, reinforcing the company's international growth trajectory.

For those interested in learning more about Solvias' new Center of Excellence in RTP, further details can be found at solvias.com.

About Solvias

Established to provide top-notch CMC analytics to the life sciences sector, Solvias is headquartered near Basel, Switzerland. Its expert team merges decades of scientific experience with regulatory expertise across various domains, including small molecules, biologics, and cell & gene therapies. Offering end-to-end solutions from raw material testing to drug product launch and API development, Solvias adheres to the highest ISO, GMP, GLP, and FDA standards across its global facilities.