This project is funded by the Economic Development Administration (EDA Award # 01-79-14889). The team’s main focus is to work with the pharmaceutical sector here in Puerto Rico by:
- Stimulate investment in Process Analytical Technology (PAT) and Continuous Manufacturing to increase the competitiveness and resiliency of our pharmaceutical industry.
- Provide capacity-building modules with a Mobile Training Unit to help industrial participants develop strong business cases for proposed investments.
- Develop a PAT & continuous manufacturing ecosystem which will facilitate the growth and strengthening of engineering validation and automation service companies in support of PAT, continuous and advanced manufacturing.
For too long, the discussion of the business and scientific aspects of the pharmaceutical industry have been separate unrelated topics. We want to bring these two worlds together.
A series of capacity-building modules were offered as video conferences in to two cohorts of representatives from Puerto Rico’s pharmaceutical companies and engineering, validation, automation, and services (EVAS) companies. These modules have had a total of 93 participants, of these 13 pharmaceutical companies and from 8 engineering, validation, automation, and service (EVAS) companies have participated.
A link is included below each module description. This link includes a recording of the module and supplementary material for each respective topic.
The first module discussed How the Process Analytical Technology initiative evolved and provided a regulatory perspective. This module also includes examples of how PAT is part of the ICH guidelines.
Module #1 – PAT Goals and Regulatory Perspective
The second module is focused on PAT – Opportunities to Increase Competitiveness and Resilience. This session discussed specific opportunities such as the identification of raw materials by NIR and Raman spectroscopy, predictive models for tablet dissolution, and others.
The third module is on Raw Material Identification Using Raman and NIR Spectroscopy. This module includes examples of various equipment, material identification of several materials, equipment applications and library development.
Module 3#- Material Identification using Raman and NIR Spectroscopy
The fourth module was titled The Business Case for PAT and was presented by graduate students María Fontalvo and Dr. Mayra Méndez from the Industrial Engineering Department at UPRM. This session discussed PAT and its relationship to Lean Manufacturing and introduced a template for justifying the business case for PAT. All PAT and continuous manufacturing projects require capital investments, which are only possible once the business case is developed and approved by upper management.
Module #4- The Business Case for PAT
The fifth module discussed the Challenges when Working with PAT addressing difficulties that have often delayed projects or prevented their successful implementation. The session provided a summary of difficulties observed during 20 years of visiting industry and working with PAT scientists and performing research in our lab.
Module #5- Challenges when working with PAT
The sixth module focused on Continuous Manufacturing (CM) and was presented by Dr. Rafael Méndez and Dr. Rodolfo J Romañach. This session included the topic of process intensification, equipment used for CM, and regulatory considerations. This sixth module placed special emphasis on the benefits of CM, and its potential for improving competitiveness and resilience.
Module #6- Continuous Manufacturing
The seventh module was offered by Dr. Rodolfo J Romañach and is guided towards Chemometrics. Focusing on mathematical algorithms used to generate calibration model and other applications used in combination with PAT.
An eight and final module on Material Characterization was offered by Dr. Rafael Méndez. Material Characterization is essential for continuous manufacturing projects and process development.
Module #8- Material Characterization
Since the project goal is to increase resilience and compepetiviness of the pharmaceutical sector here in Puerto Rico through PAT and advanced manufacturing techniques. The team has aimed its efforts to providing support on PAT, CM and business case development. Efforts have been made to develop and support on two different business cases for PAT and continuous manufacturing. One of the business cases involved a stream sampler under development by our research group, and which was published by the Journal of Pharmaceutical Innovation: