Webinars
eChalk Talk: CMC Bioanalytical Control for ATMPs – Challenges and Strategies
This webinar will provide an overview of considerations relevant to representative ATMPs in the development and lifecycle of assays for potency, purity, quantity, and identity…
eChalk Talk: Bioanalytical Strategy for Immunogenicity Assessments of ATMPs
In this eChalk Talk, we will discuss the different platforms that are used to evaluate the immunogenicity of ATMPs including ligand binding assays, flow cytometry,…
Bioanalytical Strategies for Biomarker Implementation in Clinical Trials
In association with Bioanalysis Zone, this webinar will highlight how bioanalytical strategies for implementing biomarkers in clinical trials will be presented. Watch Now
Challenges and Strategies for the Bioanalysis of Protein Therapeutics and Biomarkers by LC–MS/MS
Bioanalysis of proteins by LC–MS/MS is a well-established technique in drug discovery and development. LC–MS/MS has gained popularity as a complementary approach to… Watch Now
Bioanalytical Challenges for Cellular Immunogenicity Testing Using Validated ELISpot Assays
The last few decades have seen a surge of new cell and gene therapies in drug development pipelines. The bioanalytical support for these complex modalities…
Total Antibody Assays for AAV-Based Gene Therapies – To Bridge or Not to Bridge
Assessing humoral immunogenicity is an interesting challenge for adeno-associated virus (AAV)-based gene therapies. While most people are concerned about how to deal with pre-existing antibodies……
ADC Case Studies: Overcoming Challenges in Bioanalytical and CMC Characterization
Explore ADC case studies and bioanalytical methods to overcome challenges in assay development and CMC characterization for effective biotherapeutics. Watch the on-demand webinar now. Watch…
Multiparameter Flow Cytometry as a Powerful Tool in Drug Development
Multiparameter flow cytometry has been used extensively for cell analysis in drug development. Although this technology has been around for decades, it’s now being used…
Considerations for Biodistribution and Viral Shedding Assays in Regulated Bioanalysis
Cell and gene therapies (CGT) are rapidly emerging and evolving as promising therapies for a variety of disease indications. It is important to understand the…
Potency Assays For ATMPs — Conception, Development, Validation, Matrixed Approaches And Assay Lifecycle
Advanced therapy medicinal products or ATMPs, are among the fastest growing areas of biotherapeutics, encompassing gene therapies, viral therapies, vaccines and cell therapies. The control…