HOUSTON, June 25, 2025 /PRNewswire/ — Avance Biosciences is proud to announce the launch of its Next-Generation Sequencing (NGS) Center of Excellence, a purpose-built facility designed to unify and enhance the company’s sequencing capabilities across all phases of drug development [...]
Avance Biosciences™ is proud to announce its participation in the Bioprocessing Summit 2025 in Boston, MA. Visit Booth #516 to learn how our GLP- and GMP-compliant analytical services support the development and manufacturing of biologics, cell and gene therapies, and advanced biotherapeutics...
Our existing 28,000 sq. ft. of lab space is expanding by an additional 17,000 sq. ft., enhancing our GLP, GMP and CLIA testing capabilities...
Immunogenicity assessment is critical in the development of biotherapeutics. Conventionally, this evaluation has been facilitated by employing ligand binding assays (LBAs). However, the development of immunogenicity assays by LBA can present certain challenges in some cases, and alternative assay platforms can be advantageous. In this study, liquid chromatography with tandem mass spectrometry (LC-MS/MS) was employed [...]
The immunogenicity of therapeutic proteins remains a key challenge, leading to early and late-stage clinical failures, posing a significant hurdle in the development of safe and efficacious biopharmaceuticals. This review highlights the main categories of factors influencing the immune response-mediated impacts of biotherapeutics: 1) patient-related factors, 2) product-related factors, and 3) administration-related factors. It provides [...]
Ulcerative colitis (UC) and Crohn's disease (CD), pose a substantial burden, necessitating effective therapies. Etrolizumab, a unique monoclonal antibody targeting integrins, initially showed promise but was terminated due to lack of efficacy in PhIII studies. The immune responses elicited by patients towards etrolizumab make it a compelling subject for further in-depth investigation. This study delves [...]
Avance delivers end-to-end NGS workflow compliance with a robust framework for data integrity, pipeline validation, and audit readiness—tailored for regulated environments...
All biotherapeutics have the potential to induce an immunogenic response and generate anti-drug antibodies (ADAs), especially when administered as multiple doses over prolonged periods. However, a clinically meaningful effect of ADAs can be difficult to identify to communicate the impact of immunogenicity on drug exposure, safety and efficacy outcomes in product labels in a way [...]
An immunogenicity risk assessment (IRA) is a relatively new expectation of health authorities that is increasingly incorporated into the drug development process across the pharmaceutical/biotech industry. The guiding principle for an IRA includes a comprehensive evaluation of product- and patient-related factors that may influence the immunogenic potential of a biotherapeutic drug and a potential action [...]
Peptides are gaining remarkable popularity in clinical diagnosis and treatment due to their high selectivity and minimal side effects. Over 11% of all new pharmaceutical chemical entities authorised by the FDA between 2016 and 2024 were synthetically manufactured peptides. A critical factor that can potentially limit the efficacy and safety of peptide-based therapeutics or biologics [...]
