INSIGHTS ON CELL & GENE MANUFACTURING AND LOGISTICS
A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies
Establishing a robust contamination control strategy for advanced therapy medicinal products, also referred to as cellular and gene therapy products, is of utmost importance. We must employ risk assessments and risk-based approaches. In this article, the authors introduce the aseptic risk evaluation model (AREM), which is compliant with the evolving global regulatory landscape and best practices.
Formula For Pharmaceutical Logistics And Supply Chain Success In 2024
Join global logistics leaders for an in-depth analysis of the evolving pharmaceutical supply chain, exploring critical issues, emerging trends, and strategies for navigating the complexities of 2024.
The Use Of Injectable Packaging From Early Development To Commercialization
While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.
Implementing A Risk-Based Approach To Calibration
The article suggests companies may benefit from a risk-based approach to calibration. This approach uses information from User Requirement Specifications and other documents created during the manufacturing process development.
Huh? Where Did That Environmental Monitoring Hit Come From?
After decades of helping to rescue biotech and pharma companies from environmental monitoring excursions, Herman and Erich Bozenhardt bring this discussion about specific problems you should avoid.
A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis
The ASTM E55 Cleaning Team, in collaboration with F04 Medical Device Committee members, felt that the commonly used three-level criticality system was inadequate for use in a science- and risk-based standard for cleaning process development, validation, and monitoring. This article will provide a detailed discussion of how science-based and data-driven criticality levels were derived, the meaning of each level, and how they can be used for guiding the selection of risk reduction and risk control measures.
FDA’s CBER Issues Final Guidance For CAR T Cell Products
The FDA issued the final guidance document, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, on January 29. This article shares a useful and thorough summary of the guidance and where it differs (or not) from the earlier draft version of the guidance.
Inside Yescarta's Reduced Median Turnaround Time With Kite Pharma's Christopher McDonald
On this episode of Cell & Gene: The Podcast, Kite Pharma's Global Head of Technical Operations, Christopher McDonald talks to Host Erin Harris about Kite's recent FDA approval of manufacturing process change resulting in reduced median turnaround time for Yescarta. They talk through the most significant steps Kite took to reach this approval, lessons learned from having worked with the FDA, scaling up technologies for cell therapy manufacturing, and more.
New DSCSA Guidance Details Layers Of Verification System Requirements
A recent FDA final guidance interpreting the DSCSA details verification systems expectations for trading partners. Just how they should meet these expectations, however, remains unclear.
Using Relational Risk Analysis To Control Procedure Failures In The Bio/Pharma & Medical Device Industry
In the bio/pharma and medical device industries, operating procedures guide virtually every activity and are required for compliance with good manufacturing practices. Minimizing procedure execution failures is critical. To do so, you can use relational risk analysis (ReRA).