Using a closure analysis method to reduce CGT contamination risks
Many cell therapy manufacturing processes use open unit manipulations. As a result, they are at risk of potential contam...
Fill Finish
In BioPhorum Fill Finish (FF) you will find representatives of the world’s top sterile filling operations developing solutions to some of the most intractable technical and regulatory challenges.
Members have addressed the critical challenges that Annex 1 brings to final filtration integrity testing and isolator disinfection. We are now rolling out industry approaches to environmental monitoring, particle risk management, and working together to remove barriers to rapid micro adoption.
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Benefits
The BioPhorum Fill Finish mission is to develop and implement best practice processes in drug product operations. Our members benefit from:
- Developing and implementing safe, predictable, lean and agile processes in drug product operations that biopharmaceutical pipelines need now and into the future
- Strong representation of the top sterile filling operations in the world, both drug manufacturers and CMOs
- Synchronized adoption to change the landscape that regulators see across the industry in one go
Recent examples of Phorum success include:
- Established a best practice risk based approach to PUPSIT
- Reducing barrier breaks and isolator operating costs by optimizing settle plate use and even replacement with new rapid micro technologies; and reducing time to release with rapid sterility systems
- Harmonizing on the best biopharmaceutical environmental monitoring (EM) practices, to ensure the very best control and investment with the right amount and location of monitoring in existing and new facilities
- Reducing lyophilization scale-up and transfer times, and allowing for better optimization of lyo cycles and freeing-up capacity by making the application and use of mathematical models a reality at commercial scale
- Reducing particle contamination of conventional elastomeric stoppers, by promoting a strong industry voice and engaging with suppliers and other parties in a constructive way
- Providing clarity and confidence on particle classification by product type for visual inspection operations, with the use of a new harmonized risk based methodology
Workstreams
- Alternative and Rapid Microbiology Methods
- Container Closure Integrity
- Environmental Monitoring
- Isolator Good Practice
- Sterile Filtration Quality Risk Management (PUPSIT)
- Visual Inspection and Particulate Control
- Pre-filled Syringes
- Secondary Packaging
- Application of Robotics in Filling
Cross Phorum Initiatives
- In-Line Monitoring and Real-Time Release
- Virtual Inspections and Audits