Immunogenicity
Bioanalytical Strategies to Support Biosimilar Programs: How BioAgilytix is Helping to Shape Best Practices
BioAgilytix has been fortunate enough to have several of our team members participate as co-authors on all three AAPS white papers in the series on…
CRISPR-Cas9 Milestones: The First In Vivo Clinical Trial Is Now Underway in Boston
The first in-human in vivo clinical trial using CRISPR-Cas9 is now open for enrollment; we take a closer look at this genome editing technology to…
Platform Spotlight: ImmunoCAP to Support Diagnosis of Allergic Reactions Against Biologics
The observation of drug-specific IgE antibodies which may cause anaphylaxis prompts the need to test for these antibodies - but because IgE are 2000-fold less…
Immunogenicity Assessment Using the Biacore™ T200 SPR System
What are the advantages of using the Biacore™ T200 SPR System for immunogenicity assessments with a tiered approach? Our experts discuss.
To the Rescue: Applying a Novel Approach to Minimize False Positive ADA Assay Results
Target interference can cause false positive ADA assay results and stall out promising drugs. This could have been the case for one study involving an…
Immunogenicity Assessment of Gene Therapy Compounds
By Dr. Arno Kromminga and Dr. Lydia Michaut
Gene therapy has experienced an exciting resurgence in the post-genomic era, but unwanted immunogenicity is still a…
New FDA Guidance on Developing and Validating Assays for ADA Detection: Key Updates and Clarifications
The FDA’s recently released new guidance, designed to facilitate development and validation of assays for the detection of anti-drug antibodies for immunogenicity testing, includes several…
Supporting a Gene Therapy Clinical Trial with Assay to Measure NAbs Against the AAV9 Serotype
Today we're featuring a case study on how BioAgilytix developed a cell-based assay to determine the prevalence of pre-existing antibodies against the AAV9 serotype in…
Immuno-oncology in 2018: Overcoming Challenges to Revolutionize Cancer Treatment
Many immuno-oncology therapies are seeing success and showing promise for the future, including CAR-T cells, tumor-infiltrating lymphocytes (TILs), checkpoint inhibitors, and natural killer cell therapies.…
ELISA, the Most Used Immunoassay Platform in Large Molecule Bioanalysis
Biologics development is an inherently complex field. In order to carry out the stringent bioanalytical testing your studies require, you not only need expert scientists…