Immunogenicity References
Explore our curated repository of peer-reviewed publications on immunogenicity testing in drug development. Access the latest research and insights on detecting and managing immune responses to biologics, vaccines, and novel therapeutics.
Download our whitepaper on “Phage Testing of Bacterial Cultures” to understand the critical importance of mitigating phage contamination in biotech and pharmaceutical industries. Learn about the lytic and lysogenic life cycles of phages, their role in bacterial biology, and the challenges they pose to the biotech and pharmaceutical industries due to contamination. Phage presence in cultures can significantly skew results, posing challenges in bacterial identification and isolation...
Next- and third-generation sequencing are vital for GMP, GLP, and clinical applications, but data integrity challenges and 21 CFR Part 11 compliance require secure instruments, validated workflows, and robust audit trails...
Genome editing offers unprecedented precision, but off-target effects remain a key safety concern. GUIDE-Seq provides a high-throughput, genome-wide method to map CRISPR-Cas activity in living cells, enabling researchers to assess specificity and ensure safer gene-editing therapies...
Avance delivers end-to-end NGS workflow compliance with a robust framework for data integrity, pipeline validation, and audit readiness—tailored for regulated environments...
INTRODUCTION: ABvac40 is an investigational active immunotherapy (vaccine) targeting Abeta40. This study assessed the safety and immunogenicity of ABvac40 in patients with amnestic mild cognitive impairment or very mild Alzheimer's disease. METHODS: AB1601 was a multicenter, randomized, double-blind, placebo-controlled phase 2 study. Patients (n = 124) received five [...]
Bispecific antibodies (BsAbs) have emerged as a promising class of therapeutics to treat complex diseases, offering advantages in dual targeting simultaneously compared to monospecific antibodies. However, BsAbs often require advanced engineering, and the novel formats present challenges for the development of clinical anti-drug antibody (ADA) assays. Immunogenicity evaluation [...]
Avance Biosciences™ will exhibit at BPI International 2025 in Boston, showcasing our end-to-end analytical and testing services for biologics, cell, and gene therapies. Visit booth 1508 to learn about our NGS Center of Excellence, offering advanced sequencing, on/off-target detection, and gene editing safety assessments...
PTDSS1 (phosphatidylserine synthase 1) encodes an enzyme that facilitates production of phosphatidylserine (PS), which mediates a global immunosuppressive signal. Here, based on in vivo CRISPR screen, we identified PTDSS1 as a target to improve anti-PD-1 therapy. Depletion of Ptdss1 in tumor cells increased expression of interferon-gamma (IFN-gamma)-regulated genes, including B2m, [...]
CAR-T-cells can drive MHC class-I-mediated CD8 + cytotoxic T-cell response towards CAR constructs in addition to an antibody response. Immune response may also develop towards residuals present in the CAR-T cell product such as AAV, CRISPR/CAS9, and expamers. Health authorities recommend developing assays to assess both humoral and [...]
Avance Biosciences’ NGS Center of Excellence delivers comprehensive sequencing solutions, including short-read, long-read, and advanced single-cell platforms. Our regulatory-compliant workflows support biologics, gene, and cell therapy programs with high-quality data, enabling informed development...