Purpose

A template to prepare a business case for Process Analytical Technology (PAT) and Continuous Manufacturing (CM) projects is presented in this study. Business cases are necessary tools used in different organizations to present new projects for management evaluation. As new ways of working under PAT and CM constitute a significant investment of capital, time, personnel, and other resources, a solid business case will facilitate the organization, presentation, and justification of these innovative strategies to management for their evaluation. The authors understand that this is the first study that considers the implementation of PAT in a specific manufacturing facility, including potential tax benefits associated with the manufacturing location.

Methods

A financial analysis template was used to develop a business case for an innovative stream sampler for pharmaceutical powder blends. The business case financial model included the capital investment and associated costs for implementing this powder sampler. The case study modeled three different potential tax benefits modalities. The definition of the financial model parameters, assumptions, and constraints are followed by the recommendations of pharmaceutical industry leaders and tax advisors.

Results

The financial model provided the evaluation of the listed relevant costs and benefits. The analysis evidenced a significant influence of tax incentives on the economic evaluation. As a result, the financial model estimated a net present value (NPV) range of $420,957 to $578,896, an internal rate of return (IRR) with a minimal of 65% and a maximum of 89%, and a return of investment (ROI) of 82 to 133% for the proposed PAT investment. The most significant benefits representing additional savings between $14,157 and $234,157 per year were presented applying the tax incentives.

Conclusion

The PAT Business Case template facilitates evaluating different scenarios, costs, and benefits for a proposed project. Each company may adopt the business case model according to its cost structure and manufacturing processes. The tax benefits contribute further to this case study, especially the super deduction, followed by the R&D tax credit. Furthermore, the tax incentives effects can be evaluated by entering the input data without an additional step in the business case template.

中文翻译：

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制药行业流式采样器业务案例模型的开发与应用

目的

本研究介绍了为过程分析技术 (PAT) 和连续制造 (CM) 项目准备业务案例的模板。商业案例是不同组织用来展示新项目进行管理评估的必要工具。由于 PAT 和 CM 下的新工作方式构成了对资本、时间、人员和其他资源的重大投资，因此可靠的商业案例将有助于组织、展示和证明这些创新战略的管理，以便对其进行评估。作者了解到，这是第一项考虑在特定制造设施中实施 PAT 的研究，包括与制造地点相关的潜在税收优惠。

方法

财务分析模板用于开发用于药物粉末混合物的创新流采样器的商业案例。商业案例财务模型包括实施该粉末采样器的资本投资和相关成本。该案例研究模拟了三种不同的潜在税收优惠模式。制药行业领导者和税务顾问的建议遵循财务模型参数、假设和约束的定义。

结果

财务模型提供了对所列相关成本和收益的评估。分析证明税收优惠对经济评估有显着影响。因此，财务模型估计净现值 (NPV) 范围为 420,957 美元至 578,896 美元，内部收益率 (IRR) 最低为 65%，最高为 89%，投资回报率 (ROI)拟议的 PAT 投资的 82% 至 133%。最显着的好处是每年额外节省 14,157 美元至 234,157 美元，适用于税收优惠。

结论

PAT 商业案例模板有助于评估提议项目的不同方案、成本和收益。每个公司都可以根据其成本结构和制造流程采用商业案例模型。税收优惠进一步促进了本案例研究，特别是超额扣除，其次是研发税收抵免。此外，可以通过在业务案例模板中输入输入数据来评估税收激励效果，而无需额外的步骤。