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LyoHUB

Evidence Tier:DOCUMENTED

Published in academic literature

For:Researchers & AcademicsIndustry Professionals

App Summary

LyoHUB provides news and resources from the Lyophilization Technology Hub and includes the LyoPRONTO tool for researchers and professionals to simulate and optimize freeze-drying processes. The associated research describes the tool's use of 1D heat and mass transfer analysis, which reduced primary drying time by up to 62% for a 5% mannitol solution compared to typical cycle conditions. The authors conclude that this optimization can minimize operational costs and pave the way for more efficient freeze-drying cycle design.

App Screenshots

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Detailed Description

Functionality & Mechanism

Developed by LyoHUB, this application serves as an informational portal and integrates a powerful lyophilization simulation tool, LyoPRONTO. The tool's modules execute simulations of freezing and primary drying stages using 0D lumped capacitance and 1D heat and mass transfer models. The interface facilitates the generation of a process design space based on user-defined inputs. From this space, the system computes and displays optimal, time-varying setpoints for chamber pressure and shelf temperature to minimize drying time.

Evidence & Research Context

The tool's design and performance are detailed in an associated research article that presents preliminary validation data.

  • The primary drying calculator demonstrated a predictive accuracy with an average deviation of 3% from experimental measurements.
  • For a 5% mannitol solution, the optimization algorithm reduced primary drying time by 62% compared to typical cycle conditions.
  • For a 5% sucrose solution, the optimizer achieved a 50% reduction in primary drying time.
  • The authors propose the underlying optimization models could inform the development of advanced, automated freeze-drying control systems.

Intended Use & Scope

Intended for researchers, formulation scientists, and process engineers involved in lyophilization development. The application functions as a modeling and process optimization tool for designing freeze-drying cycles prior to physical experimentation. The tool is not a real-time process control system, and all model-derived parameters require empirical validation in a specific laboratory or manufacturing setting.

Studies & Publications

1 publication

Peer-reviewed research associated with this app.

Development/Design Paper

LyoPRONTO: an Open-Source Lyophilization Process Optimization Tool

Shivkumar et al. (2019) · AAPS PharmSciTech

Describes the research-driven development of this app
Abstract This work presents a new user-friendly lyophilization simulation and process optimization tool, freely available under the name LyoPRONTO. This tool comprises freezing and primary drying calculators, a design-space generator, and a primary drying optimizer. The freezing calculator performs 0D lumped capacitance modeling to predict the product temperature variation with time which shows reasonably good agreement with experimental measurements. The primary drying calculator performs 1D heat and mass transfer analysis in a vial and predicts the drying time with an average deviation of 3% from experiments. The calculator is also extended to generate a design space over a range of chamber pressures and shelf temperatures to predict the most optimal setpoints for operation. This optimal setpoint varies with time due to the continuously varying product resistance and is taken into account by the optimizer which provides varying chamber pressure and shelf temperature profiles as a function of time to minimize the primary drying time and thereby, the operational cost. The optimization results in 62% faster primary drying for 5% mannitol and 50% faster primary drying for 5% sucrose solutions when compared with typical cycle conditions. This optimization paves the way for the design of the next generation of lyophilizers which when coupled with accurate sensor networks and control systems can result in self-driving freeze dryers.
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In the Media

LyoHUB2040 Technology Roadmap for Pharma/Biotech Manufacturing

Purdue University's Advanced Lyophilization Technology Hub (LyoHUB) developed the Lyo2040 Technology Roadmap to improve pharmaceutical and biotechnology manufacturing processes, collaborating with over 100 industry experts and receiving support from a National Institute of Standards and Technology grant. "Our technology roadmap lays out ongoing research goals to improve process efficiency and cost-effectiveness and explore alternative drying techniques," said Alina Alexeenko, LyoHUB director and professor of aeronautics and astronautics and chemical engineering. The roadmap was unveiled on Manufacturing Day as part of efforts to strengthen domestic pharmaceutical manufacturing and supply chains.

PurdueRead article

LyoHUB2040 Technology Roadmap for Pharma/Biotech Manufacturing to be launched Oct. 4

Purdue University's Advanced Lyophilization Technology Hub (LyoHUB) developed the Lyo2040 Technology Roadmap to advance pharmaceutical and biotechnology manufacturing, collaborating with over 100 industry experts and receiving support from a National Institute of Standards and Technology grant. "Our technology roadmap lays out ongoing research goals to improve process efficiency and cost-effectiveness and explore alternative drying techniques," said Alina Alexeenko, LyoHUB director. The roadmap launched on October 4, Manufacturing Day, focusing on improving lyophilization processes that preserve temperature-sensitive products like vaccines and biologics.

PurdueRead article

LyoHUB adds new course in freeze-drying to resources that can assist COVID-19 research in diagnostics, therapeutics and vaccines

Purdue University's LyoHUB developed a new free online course in pharmaceutical freeze-drying to assist COVID-19 research in diagnostics, therapeutics and vaccines, using eight 20-minute modules created by leading lyophilization experts nationwide. "Lyophilization removes water at low temperature and low pressure, safely drying sensitive drugs," said Elizabeth Topp, co-founder and co-director of LyoHUB. The course was developed through a grant from the National Institute for Innovation in Manufacturing Biopharmaceuticals and includes virtual laboratory exercises.

PurdueRead article

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