PDA Midwest: Contamination Control in Cell & Gene Therapy Facilities

Columbus, OH
Ask a Question

Join PDA Midwest Chapter for a dinner meeting focusing on Contamination Control in Cell & Gene Therapy at the Watershed Kitchen & Bar in Columbus, Ohio. Enjoy the atmosphere, current topics, and the opportunity to network with your peers during the welcome/registration hour starting at 5:00 pm. Private distillery tours start at 6:00 pm. Dinner will be served at 6:45 pm with the presentation following shortly thereafter.

Presented by: Claire Briglia, Principal, Vedere Solutions, LLC.

Abstract: Advanced Therapy Medicinal Products (ATMP) are moving quickly into a commercial-stage and have many challenges around microbial contamination control and monitoring. According to the Personalized Medicine Coalition, "25 of the 59 new molecular entities FDA approved in 2018 are personalized medicines." In 2018, FDA drafted "Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)" to provide the industry with their current thinking on this unique new treatment. Patient safety needs to be considered carefully at each manufacturing step with a risk-based approach. This presentation will describe all the elements of a robust contamination control master plan for ATMP manufacturing.

Standard Registration

Member Price


Day 1

  • 5:00 pm - 6:00 pm Registrations
  • 6:00 pm - 6:45 pm Private Distillery
  • 6:45 pm - 7:30 pm Dinner
  • 7:30 pm - 8:30 pm Presentation
Agenda is subject to change.

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Watershed Kitchen and Bar

1145 Chesapeake Ave
Columbus, OH ,