What unites and drives the members to collaborate in BPOG FF are several shared goals. To agree how to demonstrating their control levels in an effective way to agencies, to move new techniques forward in our risk averse environment and to work together to develop the error proof, high flexibility operations we all need.
The current Fill Finish collaboration program is targeting a number of transformational operational improvements. While some of these benefits are easy gains for members, they also recognize that in our regulated environment it makes sense to move together. For this reason, in many cases companies plan synchronized adoption to change the landscape that regulators see across the industry in one go.
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.
PHORUM INFLUENCE (PI):