Webinars
eChalk Talk: CMC Bioanalytical Control for ATMPs-Challenges and Strategies
Sr. Director of CMC Bioanalytical Services, Jeff Patrick, PhD, and Scientific Officer, Michelle Miller, PhD, provide an overview of considerations in the development and lifecycle…
eChalk Talk: Bioanalytical Strategy for Immunogenicity Assessment of ATMPs
Due to the complexity of ATMPs, it is critical to evaluate the potential immune responses to these novel drugs as it can impact both safety…
eChalk Talk: Bioanalytical Strategy for PK Assessments of ATMPs
The emergence of advanced therapeutic medicinal products (ATMPs), such as cell and gene therapies, has led to the increased utilization of specialized technology platforms in…
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 ligand-binding assays…
Bioanalytical Challenges For Cellular Immunogenicity Testing Using Validated ELISpot Assays
Advanced modalities do not easily lend themselves to the standard approaches for quantitating drug product as small and large molecule therapeutics do. Technologies such as…
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…
Bioanalytical Strategies for Oncolytic Virus Therapeutics
Oncolytic viruses for the treatment of cancer and genetic disease has been an area of active study for decades. Testing strategies for monitoring efficacy and…