Abstract
In biopharmaceutical manufacturing, a new single-use technology using disposable equipment is available for reducing the work of change-over operations compared to conventional multi-use technology that use stainless steel equipment. The choice of equipment technologies has been researched and evaluation models have been developed, however, software that can extend model exposure to reach industrial users is yet to be developed. In this work, we develop and demonstrate a prototype of an online decision-support tool for the multi-objective evaluation of equipment technologies in sterile filling of biopharmaceutical manufacturing processes. Multi-objective evaluation models of equipment technologies and equipment technology alternative generation algorithms are implemented in the tool to support users in choosing their preferred technology according to their input of specific production scenarios. The use of the tool for analysis and decision-support was demonstrated using four production scenarios in drug product manufacturing. The online feature of the tool allows users easy access within academic and industrial settings to explore different production scenarios especially at early design phases. The tool allows users to investigate the certainty of the decision by providing a sensitivity analysis function. Further enrichment of the functionalities and enhancement of the user interface could be implemented in future developments.
Highlights
Biopharmaceuticals represent a growing fraction of pharmaceutical production and can be used for the treatment of many diseases such as cancer, rheumatism, or nephrogenic anemia
Drug product (DP) manufacturing involves compounding of the active pharmaceutical ingredient (API) to the final concentration and sterile filling into vials or syringes
Our current work presents a decision-support tool for drug product (DP) manufacturing processes of biopharmaceuticals, considering the choice of single-use technology (SUT), multi-use technology (MUT), and hybrid alternatives as equipment materials to be the key decision
Summary
Biopharmaceuticals represent a growing fraction of pharmaceutical production and can be used for the treatment of many diseases such as cancer, rheumatism, or nephrogenic anemia. SUT can replace the conventional multi-use technology (MUT) featuring reusable stainless steel equipment, which requires cleaning and sterilization for change-over. The authors have presented a framework for the multi-objective evaluation of equipment choice in sterile filling applications of DP manufacturing [12,13] Another layer of complexity in the decision-making process is the consideration of hybrid equipment technology alternatives combining both resin-made and stainless-steel-made equipment in the same process. Pharmaceutical production is often carried out in relatively small-scale batches and involves more complex chemical and biological interactions where data can sometimes be unavailable Another difference in pharmaceutical production is the change-over operations required to ensure equipment readiness. Our current work presents a decision-support tool for DP manufacturing processes of biopharmaceuticals, considering the choice of SUT, MUT, and hybrid alternatives as equipment materials to be the key decision. The development of the tool allows potential industrial users access to the models and algorithms developed in an academic field
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