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. As the number of products in development increases and the types of biopharmaceutical products widen, the challenges associated with current aseptic manufacturing processes must be addressed.
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 ten years. The team categorized them as:
- Core – basic, must-have capabilities in line with GMP or other regulatory requirements
- Best in class – capabilities needed and already in use in edge cases or small-scale lines today
- Aspirational – capabilities that do not yet exist but are vital in meeting the manufacturing scenarios of the future.
We have created this paper as an umbrella document and the Commercial Lines of the Future workstream will now work to develop detailed user requirement specifications focusing on specific areas in the paper. This user vision will undergo periodic reviews to keep it aligned in terms of changing technology and the regulatory landscape, including the implementation of the revision to Annex 1.
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.