基本信息
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个人简介
Background
Dr. Romañach is Professor of Chemistry at the University of Puerto Rico at Mayagüez, and Site Leader for the Engineering Research Center on Structured Organic Particulate Systems (https://www.c-sops.org/). He worked in the pharmaceutical industry for over 12 years before joining the Chemistry Department in 1999. His research is focused on developing near infrared spectroscopic methods to achieve real time quality control .
Dr. Romañach is committed to training the future generation of pharmaceutical scientists and has created Pharmaceutical Analytical Chemistry and Chemometrics courses at his university. His graduate students developed the PAT methods for the continuous manufacture of Prezista in collaboration with Rutgers and the Center for Structured Organic Particulate Systems (C-SOPS). The successful Prezista project also included short courses for Janssen personnel offered by his group as part of the PAT Certification program organized by IBS Caribe. Dr. Romañach is also one of the editors of the book Pharmaceutical Blending and Mixing, published by Wiley.
Service
Dr. Romañach is currently chair elect of the National Institutes for Pharmaceutical Technology and Education (NIPTE), which brings together 15 leadings schools of Pharmacy and Pharmaceutical Engineering to improve the way medicines are designed, developed and manufactured to meet the needs of patients in the 21st century.
Thanks to the support of the Sloan Foundation and NACME funding has been provided to PhD students in the Department of Chemistry and the other seven PhD programs at UPR-Mayaguez. These funds have allowed collaborations with other Universities and permitted research internships at multiple collaborating institutions.
He has also participated in the organizing committee of the IFPAC Summer Summit on PAT and Quality by Design for over 15 years. This conference brings together Puerto Rico's top pharmaceutical scientists who are dedicated to improving manufacturing processes.
Research
Our research is focused on understanding and reducing the sampling and analytical errors that affect the analytical methods used in Process Analytical Technology systems. Our niche is determining drug concentration in flowing powders (feed frame, chute, stream sampler) guided by the Theory of Sampling (Romañach , R. J.; Méndez, R.; Esbensen, K. H., Application of TOS principles for real-time monitoring of pharmaceutical powder blends by Near Infrared Spectroscopy", Spectroscopy Europe, 2019, 31 (5), 24-29.
Our group's motto is "We have moved to manufacturing", as we envision a future where the analytical laboratory is embedded within the manufacturing area.
A total of 10 students have completed their Ph.D. in this group:
Adriluz Sanchez Paternina (2021), Abbvie.
Barbara B. Alvararado Hernandez (2020), UPRM
Carlos Ortega Zuniga (2019), Rutgers Biochemical and Chemical Engineering Dept
Eduardo Hernandez Torres (2019), Eli Lilly del Caribe, Carolina, PR
Jenny M. Vargas (2017), Astra Zeneca
Yleana Colón (2016), PAT Scientist Janssen, Gurabo
Andres Roman Ospino (2016), Lyndra Therapeutics
Miriam Fontalvo (2016), Professor of Chemistry, Universidad del Atlántico, Colombia.
Jackeline Jerez Rozo (2014), PAT Scientist, Merck, Las Piedras, PR.
Jorge Ropero (2014), Professor of Chemistry, Universidad del Atlántico, Colombia.
Teaching
The QUIM 6835 Chemometrics graduate level course was created and taught through a number of experiments. QUIM 8008 - Scientific Communication in Chemistry is taught emphasizing avoiding clutter, following the style described in "On Writing Well" by William Zinsser.
Dr. Romañach also enjoys teaching continuing education courses to industrial scientists. Continuing education courses are his "roots", where he developed his teaching skills before coming to UPR-Mayaguez.
He also created QUIM 5205 - Pharmaceutical Analytical Chemistry, an advanced undergraduate level course open to both undergraduate and graduate students. The first part of the course addresses two important questions:
1. What does an industry, company, or business do?
2. How does a company sell a product?
The second part discusses the drug discovery and development process. The third part includes formulations and manufacturing processes, as well as Quality by Design and Process Analytical Technology (PAT). These three initial parts provide students with an introduction to the pharmaceutical industry.
The fourth part includes the study of the analytical methods that provide valuable information to the pharmaceutical industry. This section includes High Performance Liquid Chromatography (HPLC), X-Ray diffraction, mid and near infrared spectroscopy, thermal analysis, Raman spectroscopy, and methods for particle size distribution. The fourth part also includes topics of high pharmaceutical importance such as: polymorphism, quality by design, and the current good manufacturing practices (cGMPs).
研究兴趣
论文共 91 篇作者统计合作学者相似作者
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Lennart Zimmermann,Hung Lin Lee, Aibolat Koishybay,Cornelis P. Vlaar,Jean-Christophe M. Monbaliu,Rodolfo J. Romañach,Md. Noor-E-Alam,Allan S. Myerson,Torsten Stelzer
Journal of Chemical & Engineering Data (2024)
Journal of Advanced Manufacturing and Processing (2023)
Journal of Pharmaceutical Innovationno. 1 (2022): 182-194
How to Design and Implement Powder-To-Tablet Continuous Manufacturing Systemspp.93-118, (2022)
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作者统计
#Papers: 93
#Citation: 1845
H-Index: 25
G-Index: 41
Sociability: 5
Diversity: 2
Activity: 35
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