Explore our QC testing solutions short video series and high-level infographic to learn how to accelerate your development and release to market
Whether you manufacture your ATMP in-house or outsource to a CDMO, it’s important to understand the critical points for quality control, and how they protect your product (and your patients) from contamination. Quality control tests for bacterial endotoxins, rapid microbiological contamination, and identification are critical during commercialization, but also provide significant benefits when used on early Research Use Only (RUO) samples.
Video 1 - Modern Methods for Transformative Therapies: Endotoxin Detection for Cell and Gene Products
Listen to Alan Hoffmeister, Senior Technology & Market Development Manager at Charles River, to learn:
- The inner workings of the FDA-licensed cartridge technology and why it’s the leading solution among CGT manufacturers for rapid, quantitative endotoxin analysis
- How replacing subjective, laborious methods, with an automated compendial one can reduce human error and provide real-time, quantitative results in just 15 minutes
- How a CAR-T cell production facility leveraged the Endosafe® nexgen-PTS™ to streamline their testing and ensure product quality
Video 2 - Faster Micro QC Release for Cell-based Therapies: A Complete Rapid Solution using Celsis® Platform
Listen to Lucia Ceresa, Senior Technology & Market Development Manager (Retired) at Charles River, to learn:
- Challenges of traditional testing and rapid microbial method solutions for short shelf-life and ATMP testing
- How the Celsis Adapt™ works for cell-based samples, where it fits into manufacturing processes, and the various applications for use
- Outsourcing services to support the effective implementation of Celsis Adapt™
Video 3: Effective Contamination Control Strategy for Cell and Gene Products: The Importance of Accurate Microbial Identifications
Listen to Duncan Barlow, Technology & Market Development Manager at Charles River, to learn:
- Key elements of a Contamination Control Strategy (CCS) in CGT and how to mitigate risk at various stages of the aseptic production lifecycle
- Different methods of identification, their accuracy, and appropriateness for use
- How to best leverage experts to maximize for expediency and accuracy of your contamination control strategy
Video 4: Rapid Microbiological Methods: From Regulatory Requirements to Use in Routine for ATMPs
Listen to Lucia Ceresa, Senior Technology and Market Development Manager (Retired), at Charles River to learn:
- cGMP for quality systems in biologic or ATMPs manufacturing
- Updates to Annex 1 EU GMP regarding the use of rapid methods in quality control processes
- Industry guidance from Ph. Eur. 2.6.27 and USP <1071> regarding cell-based preparations and short shelf-life products
