Crystallization Design Institute

The is very thrilled to welcome Rachel N. Blundell Alemán. She is a curious and driven Ph.D. graduate student whose research centers on understanding solvent solid solutions entrapped within crystalline organic molecules, with the goal of gaining greater control over materials at the molecular level. Beyond the lab, she is a Certified Medical and Community Interpreter. She enjoys playing rugby, attending raves, crocheting, and spending time with her cat. Her interests reflect both her creativity and curiosity. Always eager to learn and grow, Rachel brings enthusiasm and a knack for knowledge to everything she does. As a new member of CDI, she looks forward to contributing, collaborating, and continuing to expand her horizons. Welcome to Rachel!

We are excited to share that our latest research has been published in Nucleic Acid Insights (https://doi.org/10.18609/nuc.2026.011).

The paper presents an integrated, continuous end-to-end platform for cGMP mRNA manufacturing, developed as part of the broader effort to rethink how mRNA therapeutics are produced.

We explore how combining IVT, precipitation-based purification, TFF, LNP formulation, and continuous lyophilization, together with modeling and digital twins, can enable scalable, flexible, and fully continuous production.

Many thanks to all co-authors Maria del Carme Pons | Torsten Stelzer | Aaron Cowley | Bernhardt Trout | Allan Myerson | Richard D. Braatz for the great collaboration.

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Integrated continuous cGMP platform for end-to-end mRNA manufacturing mRNA has evolved from a niche research technology into a major therapeutic platform, with its impact clearly demonstrated during the COVID-19 pandemic. While mRNA vaccines achieved unprecedented development timelines and strong clinical outcomes, limitations in production capacity, supply chains, an...

We are thrilled to welcome Rebeca M. Peña-Silva to . Rebeca is a third-year undergraduate student, pursuing a bachelor’s degree in chemistry at the University of Puerto Rico-Río Piedras campus. At the CDI, she will work alongside Dr. Suresh Manivel, focused on polymer-based formulation development. In the future, she aspires to earn a Doctor of Pharmacy degree, with an interest in hospital pharmacy or pharmaceutical compounding. Beyond laboratory work, she enjoys reading, coffee time, the beach, spending time with her family, and dog. Welcome to , Rebeca!

We are excited to share that our latest research on solid-liquid mixing in small-scale crystallizers has been published in 𝘐𝘯𝘥𝘶𝘴𝘵𝘳𝘪𝘢𝘭 & 𝘌𝘯𝘨𝘪𝘯𝘦𝘦𝘳𝘪𝘯𝘨 𝘊𝘩𝘦𝘮𝘪𝘴𝘵𝘳𝘺 𝘙𝘦𝘴𝘦𝘢𝘳𝘤𝘩 as part of the special issue “𝘔𝘢𝘳𝘤𝘰 𝘔𝘢𝘻𝘻𝘰𝘵𝘵𝘪 𝘍𝘦𝘴𝘵𝘴𝘤𝘩𝘳𝘪𝘧𝘵” (https://doi.org/10.1021/acs.iecr.5c04538).

Although mixing is often overlooked in lab-scale crystallizers (≤100 mL), our work highlights its critical role for achieving suspension uniformity, which significantly alters the crystallization performance.
In this publication, we used computational fluid dynamics (CFD) simulations to systematically investigate the impact of stirring rate, impeller type, blade geometry and number, dual-impeller configurations, and baffles on the mixing performance.

Many thanks to all co-authors and collaborators:
Albertazzi | V. Pandit | Aprile | del Carme Pons Royo | Busini | Rota | S. Myerson | Stelzer

This work was supported by the National Science Foundation (NSF) under the Advanced Manufacturing Program (CMMI-2242255).

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Computational Fluid Dynamic Study in a Multistage Small-Scale Tower Crystallizer The solid–liquid hydrodynamics in a novel tower crystallizer consisting of seven vertically stacked spherical mixed-suspension, mixed-product removal crystallizers is reported. Mixing in spherical geometries remains underexplored. Therefore, computational fluid dynamics (CFD) simulations (Eulerian...

What better way to start 2026 than with a new publication. Check out our most recent review, now published in 𝘊𝘩𝘦𝘮𝘉𝘪𝘰𝘌𝘯𝘨 𝘙𝘦𝘷𝘪𝘦𝘸𝘴! https://doi.org/10.1002/cben.70040 ⁣

The review explores continuous precipitation as an enabling technology for biotherapeutic purification, addressing key downstream bottlenecks as upstream titers continue to increase. We discuss how precipitation can serve as a scalable and continuous alternative to traditional chromatography, and outline the critical design elements needed for successful implementation, including thermodynamics, process modelling, hardware designs, and real-time monitoring.

Many thanks to all our co-authors and collaborators at MIT: Maria del Carme Pons Royo | Vico Tenberg | Allan Myerson, and Richard D. Braatz for the fantastic collaboration.

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Continuous Precipitation of Biotherapeutics: A Review Continuous precipitation is emerging as a powerful alternative to chromatography for purifying biotherapeutics, enabling scalable and efficient downstream processing. This review highlights key desig...

Our latest publication in the International Journal of Pharmaceutics (https://doi.org/10.1016/j.ijpharm.2025.126197) highlights the fact that “no product design without process design (control)”.

In this work, we are utilizing crystallization as a tool for product design in a proof-of-concept solution-based additive manufacturing approach to produce a solid dosage form inside a capsule carrier. By controlling the evaporative crystallization process the API crystallizes within a polymer matrix to generate a crystalline solid dispersion with polymorph control. The quality attributes of these dispersions have been tested and match those of commercially formulated tablets. This platform offers several advantages:
1. Eliminates known powder handling challenges of conventional multi-step solid dosage manufacturing.
2. Reduces the number of unit operations via process intensification.
3. Developed workflow and insights provide a generalizable approach applicable to other API – polymer – solvent systems, independent if crystalline or amorphous solid dispersion is needed.

Ultimately, our study is part of a three publication series that highlights efforts towards integrated end-to-end pharmaceutical manufacturing needed, e.g., for point-of-use manufacturing in remote areas or for personalized medicine through flexible (additive) formulation.

Thanks to all co-authors and collaborators:
Aliou Mbodji | Kelitsha Mulero Cruz | Andrea Arroyo Gomez | Cornelis Vlaar | Jorge Duconge | Jean-Christophe Monbaliu | Rose Cersonsky | Lian Yu | Geoff Zhang | Gerard Coquerel | Rodolfo Romanch | Torsten Stelzer

This work was supported by the National Aeronautics and Space Administration, the National Science Foundation (NSF) Wisconsin - Puerto Rico Partnership for Research and Education in Materials, as well as the UPR-UW PREM: Center for Advancing Research and Training for STEM Success.

We are thrilled to welcome Paloma Báez Brull as part of the . Paloma is a fourth-year undergraduate student pursuing a bachelor’s degree in chemistry at the University of Puerto Rico - Rio Piedras campus. At the CDI, she will work alongside Dr. Aliou Mbodji, focused on continuous crystallization. In the future, Paloma aspires to obtain a Doctor of Pharmacy with an interest in clinical pharmacy. Beyond laboratory work, she enjoys the beach, reading, and spending time with friends and family. Welcome to the Paloma!

The Crystallization Design Institute is thrilled to welcome Nathan Gallegos to the . Nathan is a fourth-year undergraduate student pursuing a bachelor’s degree in chemistry at the University of Puerto Rico, Rio Piedras Campus. At the CDI, he will work alongside Dr. Suresh Manivel, focused on Polymer-Based formulation development. In the near future, Nathan aspires to obtain a Ph.D. in forensic chemistry and continue research on the topic. Beyond laboratory work, he enjoys reading, relaxing with coffee, and just taking time to unwind with simple things. Welcome to , Nathan!

We are excited to share our latest publication in Nature Chemical Engineering (https://doi.org/10.1038/s44286-025-00268-w) commenting on the persistent barriers to the adoption of continuous crystallization in the pharmaceutical industry.

Despite successes in other industries, widespread implementation in pharmaceutical manufacturing remains limited. Together with a team of authors from academia and industry we comment on the institutional, operational, and technical challenges.

This piece reflects our ongoing commitment to identifying and overcoming these barriers through collaborative research to unlock the full potential of continuous pharmaceutical manufacturing.

Thanks to all co-authors for their insights and collaboration:
Giovanni Aprile | Cedric Devos | Thomas Vetter | Gerard Capellades | Kevin Girard | Christopher Burcham | Venkat Bhamidi | Daniel Green | Torsten Stelzer | Richard D. Braatz | Allan Myerson

Giovanni Aprile was supported by the National Science Foundation (NSF) under the Advanced Manufacturing Program (CMMI-2242255). We also thank all researchers from industry and academia that contributed to the discussion during the AIChE Annual Meeting 2024 in San Diego (USA).

Reflecting on barriers to continuous pharmaceutical crystallization - Nature Chemical Engineering This Comment explores why continuous crystallization, despite its success in other industries, remains underutilized in pharmaceutical manufacturing. Among other challenges, we highlight two core issues: the lack of off-the-shelf small-scale equipment with integrated monitoring tools, and the absenc...

Our latest publication in Crystal Growth and Design (https://lnkd.in/eSGtD9Kd) explores the effect of structurally similar dopants on the polymorphism and crystallization of the antifungal Posaconazole.

Polymorphism and crystallization impact drug performance and stability, making it essential to understand the effect of inactive ingredients, such as surfactants, on the solid form and crystallization kinetics.

We found that the two surfactants, Tween 80 and Span 80, similarly increased the growth rates of both Posaconazole polymorphs, but differed in their impact on nucleation rates. Applying the classical nucleation theory to pure and doped melts revealed a surprisingly simple explanation for the effect of the chemically distinct but structurally similar surfactants on the crystallization.

Congratulations to the authors Kennedy Setter | Xin Yao | Rose Cersonsky | Torsten Stelzer | Shuang Chen | Ahmad Sheikh | Geoff G. Z. Zhang | Lian Yu

This work was funded by the National Science Foundation (NSF) Wisconsin - Puerto Rico Partnership for Research and Education in Materials, the UPR-UW PREM: Center for Advancing Research and Training for STEM Success, and AbbVie. We also thank the UW-Madison Wisconsin Center for Nanoscale Technology for allowing us the use of facilities and instrumentation, which is partially supported by the Wisconsin Materials Research Science and Engineering Center.

Congratulations to Leah Alvarado and Karimar Dealba Lopez on successfully completing their UPR-MAPS REU 2025 Program, funded by the National Science Foundation, at the Crystallization Design Institute. Thank you for your valuable contributions and enthusiasm for research. Wishing you all the best in your future endeavors. We look forward to future collaborations!