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PDA Midwest: Contamination Control in Cell & Gene Therapy Facilities

Apr 16 - Apr 16, 2020
Columbus, OH

  • Chapter
Cancelled

Overview

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.

Agenda

    • 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

Travel

Watershed Kitchen and Bar

1145 Chesapeake Ave
Columbus, OH

Directions

Registration Fees

Regular Price
Registration Type Price By April 16th
PDA Member $40.00
PDA Non-Member $40.00

Free parking is available in marked spots. Additional paid parking is available in the lot across from Watershed Kitchen & Bar on Chesapeake Ave.



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