Faster Micro QC Release for Cell-based Therapies: A Complete Rapid Solution
: 27 Sep 2022
Sector : Pharmaceutical
Type : Webinar
The ROAD TO PHARMA MICROBIOLOGY CONGRESS 2022 presents:
Faster Micro QC Release for Cell-based Therapies: A Complete Rapid Solution using Celsis® platform – FREE WEBINAR.
The traditional sterility test is a known limitation for the release of many cell therapies, advanced therapy medicinal products, and especially short shelf-life products. Therefore, therapies are administered at-risk to the patient while awaiting the 14-day compendial test results. This at-risk period is even greater when considering the manual aseptic processing steps involved in their production, in contrast to the primarily closed-loop process in pharmaceutical manufacturing. So why continue to rely on traditional methods to ensure patient safety a week or more after administration, especially when easy, rapid solutions exist?
Safely release cell and gene therapies in as little as three days using Celsis Adapt™ and Celsis® instrument, a pharma-proven Rapid Microbial Method that is compatible with a broad of cell types, densities, and product matrices. As the latest addition to the Celsis rapid microbiological detection platform, the Celsis Adapt™ is designed specifically to remove the cellular debris found in cell and gene therapy samples or in-process cell culture samples.
You will learn:
- How Celsis Adapt™ works for cell-based samples, where it fits into manufacturing processes and the various applications for use.
- The regulatory landscape of cell-based products and the validation requirements for samples tested utilizing Celsis Adapt™.
- Challenges of rapid microbial methods for short shelf-life and ATMP testing.
- Successful approaches to proving equivalence to traditional Micro QC methods.
- Services to support the effective implementation of Celsis Adapt™.
Join Lucia Ceresa, Senior Technology & Market Development Manager – Charles River Laboratories, for this 60-minute webinar.
Register here or use the green "Request Information" button below to contact the event organizer for details.