Potency and Cell-Based Assay Center Opened by Avance Biosciences

Avance Biosciences opened its new Potency and Cell-Based Assay Center of Excellence, a purpose-built facility designed to expand and centralize the company’s capabilities in potency and functional cell-based assays under GMP compliance. Located in Houston, the Center supports clients across the development and manufacturing of biologics, RNA therapeutics, vaccines, and cell and gene therapies, according to company officials, who add that the Center is equipped with advanced instrumentation and led by experienced cell biologists and assay development specialists.

Key service offerings include:

• Custom potency assay development tailored to product mechanisms of action
• Fit-for-purpose potency assay qualification and/or validation in accordance with ICH Q2(R2)
• GMP-compliant potency assay sample testing for clinical and commercial programs

Avance Biosciences has long been involved in working on regulated biologics and cell-based assay development. The new Center strengthens the company’s ability to provide “precise, reproducible, and scientifically robust potency data,” supporting advanced therapeutic modalities with confidence, says Xuening (James) Huang, PhD, CEO Avance Biosciences.

“With the launch of this Center, we’ve unified a world-class team and expanded our capacity to deliver complex custom assays for our growing client base,” notes Huang, “This investment reflects Avance’s continued commitment to providing industry-leading analytical and bioanalytical solutions for next-generation therapeutics.”

Avance’s potency assay team has broad experience supporting diverse modalities and platforms, including lipid nanoparticles (LNPs), monoclonal antibodies, vaccines, viral vectors, and engineered cell therapies, he continues, while pointing out that the Center centralizes these efforts, enabling faster turnaround times and standardized workflows.