Avance Biosciences offers CLIA-compliant testing services to ensure accurate, reliable data throughout drug development. From biomarker validation to regulatory support, our expertise helps biopharmaceutical companies advance clinical trials and bring innovative biologic treatments to market with confidence...
HOUSTON, Feb. 26, 2025 /PRNewswire/ -- Avance Biosciences, a leading provider of high-quality analytical and bioanalytical services for the pharmaceutical industry, is pleased to announce that it has successfully registered with the Clinical Laboratory Improvement Amendments (CLIA) program. This registration allows Avance Biosciences to operate under its assigned CLIA number and offer high-complexity laboratory testing [...]
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...
The guidance provides recommendations regarding information that should be provided in an investigational new drug (IND) application to assess the safety and quality of the investigational GE product, including information on product design, product manufacturing and testing, nonclinical safety...
In a landmark move, the FDA has initiated the Collaboration on Gene Therapies Global Pilot (CoGenT), signaling a significant leap toward worldwide collaboration in the field of gene therapy. This pilot aims to enable concurrent collaborative reviews of new gene therapy applications with global regulators…
In this draft guidance, the FDA emphasizes that potency assays and their corresponding acceptance criteria should be designed to make meaningful contributions to potency assurance by reducing risks to product potency. They provide illustrative examples of approaches to potency assay development that are...
In a groundbreaking development, the U.S. Food and Drug Administration (FDA) has approved two revolutionary treatments, Casgevy and Lyfgenia, marking a significant milestone in the field of gene therapy. These therapies represent the first-ever cell-based gene treatments for sickle cell disease (SCD) in patients...
In a landmark decision that could reshape the landscape of medicine and treatment, the United Kingdom has granted approval for the first-ever CRISPR therapy, Casgevy. This groundbreaking development marks a significant stride in the field of genetic medicine and opens up new possibilities for treating a range of...
The mRNA COVID-19 vaccines approved and authorized today are supported by the FDA’s evaluation of manufacturing data to support the change to the 2023-2024 formula and non-clinical immune response data on the updated formulations including the XBB.1.5 component...
Avance Biosciences is a leading Contract Research Organization (CRO) and Contract Testing Organization (CTO) providing CGMP and GLP-compliant analytical and bioanalytical services to support drug development. From early discovery through clinical development and commercialization, we provide CGMP and GLP-compliant services tailored to your therapeutic modality and regulatory needs.
