eChalk Talk: CMC Bioanalytical Control for ATMPs-Challenges and Strategies

  • External Link

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…

Read More

eChalk Talk: Bioanalytical Strategy for Immunogenicity Assessment of ATMPs

  • External Link

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…

Read More

eChalk Talk: Bioanalytical Strategy for PK Assessments of ATMPs

  • External Link

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…

Read More

Challenges and strategies for the bioanalysis of protein therapeutics and biomarkers by LC–MS/MS

  • External Link

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…

Read More

Bioanalytical Challenges For Cellular Immunogenicity Testing Using Validated ELISpot Assays

  • External Link

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…

Read More

Multiparameter Flow Cytometry as a Powerful Tool in Drug Development

  • External Link

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…

Read More

Considerations for Biodistribution and Viral Shedding Assays in Regulated Bioanalysis

  • External Link

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…

Read More

Potency Assays For ATMPs — Conception, Development, Validation, Matrixed Approaches And Assay Lifecycle

  • External Link

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…

Read More

Bioanalytical Strategies for Oncolytic Virus Therapeutics

  • External Link

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…

Read More