Orlando FL skyline

AAPS PharmSci 360 Annual Meeting

  • Start Date:

    22 Oct 2023

  • End Date:

    25 Oct 2023

  • Location:

    Orlando, FL

  • Region:

    North America

  • Booth #:


PPD™ Laboratory services

PPD Laboratory services combine high-quality scientific expertise with industry-leading technologies supported by a commitment to exceptional quality to deliver contract laboratory services to the pharmaceutical landscape. Our customers benefit from comprehensive lab services backed by our more than 30 years’ experience as a contract research organization. We offer a range of high-value, advanced testing services, including bioanalytical, biomarkers, central lab, GMP and vaccine sciences.


Speaker: Catherine Vrentas, principal scientist, PPD Laboratory services
This prologue talk will introduce the cell and gene therapies (CGT) symposium for the 2023 PharmSci360 Bioanalytical track. In addition to highlighting topics from each symposium speaker, the talk will discuss trends in CGT therapeutics as well as challenges and considerations for CGT bioanalysis.

Learning Objectives:

  • Gain an understanding of current trends in cell and gene therapy
  • Consider how these trends are impacting bioanalysis needs
  • Learn about the CGT symposium in this year’s PharmSci360 program

Symposium: Stability and Method Performance Considerations for Bioanalytical Enzymatic Activity Assays

Speaker: Christian Duke, manager, PPD Laboratory services
Enzymatic activity assays conducted in support of long-term cell and gene therapy clinical trials can vary in cost, complexity and performance due to reagent performance and handling, as well as reagent and sample stability. These challenges are difficult to resolve without the availability of an enzymatic reference standard. In addition, assay complexity and enzyme stability in matrix make traditional strategies for proving assay reproducibility problematic.

These results will be discussed to provide generalized approaches and considerations for long-term data continuity between patients and their respective time points.

Learning Objectives:

  • Strategies to reduce enzyme activity assay and reagent handling variability for long-term cell and gene therapy studies.
  • Strategies to monitor long-term enzyme activity assay performance to ensure continuity and minimize variability over the course of long cell and gene therapy clinical studies.

How to justify reagent retest extension to minimize variation that might be caused by introduction of new reagents that may have different activity or performance

Learn more about our bioanalytical laboratory services and our GMP laboratory services.