Amanda Versteilen

Company: Bristol Myers Squibb

Job title: Associate Director- Quality Control Analytical testing

Seminars:

Panel Discussion: Exploring Current Challenges in Cell Therapy Analytical Development 9:00 am

Addressing the multifaceted nature of analytical development, which encompasses assay development, method validation, and quality control measures tailored to the unique characteristics of cell therapy products Navigating evolving regulatory landscapes and lacking standardised guidelines complicates demonstrating product safety, efficacy, and quality Embracing emerging techniques like single-cell analysis and multi-parametric flow cytometry offers promise in overcoming challenges and improving…Read more

day: Conference Day One

Roundtable Discussion: Navigating the Chicken & Egg Dilemma – Ensuring Analytical Methods Detect Product Instability in Cell Therapy Stability Studies 3:00 pm

Explore the challenge of correlating traditional stability measurements, such as vector titer, with functional potency in cell therapy vectors.  Discuss the importance of functional potency as a critical quality attribute and the need for innovative approaches to assess it accurately over time Examine alternative study designs for stability indicating studies, including deliberately inducing stress on vectors to evaluate…Read more

day: Conference Day One