Inconsistent assay performance is a common but often overlooked cause of batch failures. Robust, reproducible analytical and bioanalytical assays help reduce risk, improve decision-making, and support reliable batch release across drug development and manufacturing...
Next-generation sequencing (NGS) outperforms Sanger for cell therapy testing, offering higher sensitivity, full-length vector analysis, and population-level variant detection to ensure genomic integrity, regulatory compliance, and scalable quality control...
Explore the FDA’s new Plausible Mechanism Pathway and how it compares to accelerated approval, expedited programs, and other regulatory routes for rare disease therapies.
The FDA released three new draft guidances to streamline cell and gene therapy development. The documents outline innovative trial designs for small populations, expedited pathways for serious conditions, and improved postapproval methods for monitoring long-term safety and efficacy...
Avance Biosciences is excited to exhibit at the ASGCT 2025 conference in New Orleans, LA, from May 13–17, 2025. Join us to explore our expert bioanalytical solutions for gene and cell therapy development. Visit booth #750 to learn how we can support your therapeutic advancements...
A new study offers hope for improving CAR-T cell therapy in treating B-cell Acute Lymphoblastic Leukemia (B-ALL), a cancer with high relapse rates. Researchers have developed an innovative approach involving a TIM-3 decoy that prevents immune evasion by leukemia cells...
Tecelra is the first FDA-approved T cell receptor (TCR) gene therapy. The product is an autologous T cell immunotherapy composed of a patient’s own T cells. T cells in Tecelra are modified to express a TCR that targets MAGE-A4, an antigen expressed by cancer cells in synovial sarcoma...
Two hallmark toxicities of chimeric antigen receptor (CAR) T-cell therapy may be rare after 2 weeks following infusion in patients with diffuse large B-cell lymphoma (DLBCL), supporting a shorter, more flexible toxicity monitoring period, according to a recent study...
Avance Biosciences™ is excited to announce our participation in the American Society of Gene & Cell Therapy (ASGCT) conference, where we’ll be showcasing our advanced services and expertise to propel the future of gene and cell therapy. [...]
CAR T-cell therapies show promise for blood cancers but struggle with solid tumors due to T-cell weakness in tumor microenvironments. Researchers find genetic alterations in cancerous T cells, giving engineered T cells "superpowers" to effectively kill tumors without behaving like cancer cells...
