User vision for the filling line of the future

Achieving aseptic excellence in drug product manufacturing is both a driving force and a constant challenge. It is becoming increasingly vital to collaborate and innovate to maintain excellence in line with technological advances but also changes to the regulatory landscape.

 

Ensuring product sterility and maintaining high-quality standards throughout the drug production lifecycle is non-negotiable, and the last decade has seen a fundamental change in the technology and solutions available for small-scale, clinical, R&D lines to meet this need by reducing and removing the potential for contamination by human intervention. However, the technology used at scale for higher-volume filling lines was established many years ago and has not kept pace with the change needed – causing inefficient processes and adding time and complexity to the filling and finishing of aseptically manufactured products.

 

To provide an overview of the future needs of the industry for aseptic manufacture, Fill Finish’s Commercial Lines of the Future workstream has published the User vision for the filling line of the future, aimed at informing and assisting equipment providers in developing the right solution for the right place. In creating this user vision, representatives from more than 20 companies identified the important high-level requirements for aseptic manufacture for the next 10 years.

 

We recognize that the realization of the user vision of the future requires collective efforts and would like to invite feedback on the paper from suppliers, integrators, and equipment manufacturers to help turn the art of the possible into the reality of the achievable.

 

For more information on how to get involved contact Kerry Ann Matthews, Senior Global Change Facilitator, at kerry.ann.matthews@biophorum.com

 

 

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User vision for the filling line of the future August 2023.pdf
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  aseptic manufacture     new technology adoption     Operations technology     URS  
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  • Create Date 22nd August 2023
  • DOI https://doi.org/10.46220/2023FF001
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Maximizing the impact of the many advanced therapies under development requires that the industry comes together to improve understanding of how to develop, control and manufacture these life changing therapies.

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Buffer stock blending system
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Closure playbook
Extractables and leachables
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