Sarah Rajani

Company: Bristol Myers Squibb

Job title: Scientist, Process Analytical Technologies

Seminars:

Utilizing Process Analytical Technology (PAT) for Identification of Critical Process Parameters (CPPs) & Critical Quality Attributes (CQAs) in the Field of Cell Gene Therapy 11:30 am

Real-time monitoring and control through PAT to detect the impact of CPPs on product quality, leading to reduced cycle times, improved resource utilization, and cost savings Exploration of PAT and new tools within the field of cell gene therapy, enabling faster analysis of personalized therapies and accelerating the speed to marketRead more

day: Conference Day Two

Roundtable: Where is Everyone’s Baseline? 3:05 pm

Discussing the available tools and measurements in PAT for cell and gene therapy development and manufacturing Comparing system and method development systems to establish a baseline for implementing PAT in the field Determining the shortest manufacturing turnaround time achieved with PAT whilst maintaining data integrity and product quality, to improve data-driven decision making and adaptive…Read more

day: Conference Day Two

Panel Discussion: Evaluating Bottlenecks with Regulatory Acceptance of PAT in Real World Applications 11:30 am

Regulatory agencies have been promotive of PAT application to improve product quality, however adoption by industry has been slower than expected, this panel will discuss common bottlenecks and misconceptions with regulatory approval for PAT in GMP environments: The application of new equipment hardware and software in regualted environments Collaborative approaches in proactive engagement with regulatory…Read more

day: Conference Day One