Some of the targeted benefits include:
- Reducing barrier breaks and isolator operating costs by optimizing settle plate use and even replacement with new rapid micro technologies.
- Harmonizing on the best bio-pharma Environmental Monitoring (EM) deployment practices, to ensure the very best control and investment profile in existing and new facilities
- Reducing lyophilisation scale-up and transfer times, and allowing for better optimization of run times and capacity by making the application and use of lyo computer 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.
BioPharma manufacturers with their own drug product / sterile filling operations and CMOs.
Suppliers are invited into the collaboration as guest to address specific product, equipment or service opportunities.