Lyophilization in Microgravity (Eli Lilly-Lyophilization) - 08.09.17

Overview | Description | Applications | Operations | Results | Publications | Imagery

ISS Science for Everyone

Science Objectives for Everyone
Lyophilization in Microgravity (Eli Lilly-Lyophilization) examines freeze-drying processes in the microgravity environment aboard the International Space Station (ISS). Freeze-drying is used to preserve food and medication but may create layering or other textures in the presences of gravity. Eli Lilly-Lyophilization freeze-dries a range of samples under microgravity conditions aboard the ISS and then returns the samples to Earth for comparison with control samples.
Science Results for Everyone
Information Pending

The following content was provided by Jeremy Hinds, and is maintained in a database by the ISS Program Science Office.
Experiment Details

OpNom: Lypholization

Principal Investigator(s)
Jeremy Hinds, Eli Lilly and Company, Indianapolis, IN, United States

Co-Investigator(s)/Collaborator(s)
Evan Hetrick, Ph.D., Eli Lilly and Company, Indianapolis, IN, United States

Developer(s)
NASA Glenn Research Center, Cleveland, OH, United States
ZIN Technologies Incorporated, Cleveland, OH, United States

Sponsoring Space Agency
National Aeronautics and Space Administration (NASA)

Sponsoring Organization
National Laboratory (NL)

Research Benefits
Scientific Discovery, Space Exploration, Earth Benefits

ISS Expedition Duration
April 2017 - September 2017; September 2017 - February 2018

Expeditions Assigned
51/52,53/54

Previous Missions
Information Pending

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Experiment Description

Research Overview

  • Lyophilization in Microgravity (Eli Lilly-Lyophilization) examines how gravity affects the physical state and properties of freeze-dried materials in the pharmaceutical industry.
  • Lyophilization or freeze-drying is commonly used in formulating pharmaceutical drug products, providing improved chemical and physical stability and is applicable to both small and large molecule pharmaceutical products.
  • The Eli Lilly-Lyophilization investigation aids in understanding the fundamental properties that impact the physical characteristics of lyophilized materials and may result in improved processes for lyophilization in the pharmaceutical industry as well as other industries.

Description

Lyophilization in Microgravity (Eli Lilly-Lyophilization) seeks to understand the influence of gravity on the physical state and properties of lyophilized materials of interest in the pharmaceutical industry. Lyophilization (i.e., “freeze-drying”) is a common method for formulating pharmaceutical drug products with improved chemical and physical stability and is applicable to both small and large molecule pharmaceutical products. Lyophilized materials are reconstituted with an appropriate diluent prior to administration to patients, typically via an intravenous route. While lyophilization affords many advantages with respect to chemical stability, it introduces other elegance and patient-safety considerations such as clarity, reconstitution time, and particulate matter, some of which may be governed by the lyophilization process itself.
 
These studies are expected to drive an understanding of the fundamental properties that impact the physical characteristics of lyophilized materials and may result in improved processes for lyophilization in the pharmaceutical industry as well as other industries. When materials are lyophilized terrestrially, the freezing and subsequent drying process leads to a “layered” product in which material forms strata that are different in macroscopic form as seen by color and or structural differences as well as in microscopic form as seen in particle size and crystal form. The factors that contribute to these differences are hypothesized to be due, in part, to gravity and the settling effect as material comes out of solution. This experiment allows us to explore several aspects of the process that would otherwise not be possible, including answers to the following questions:
  • Is the stratification the result of the freezing, or the dehydration process?
  • How is the stratification related to the resulting crystal form and particle size?
  • If there is no gravity, is there any stratification?
  • If there is not stratification, are there differences in resulting crystal form and particle size? If no, then which form is favored?

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Applications

Space Applications
Eli Lilly-Lyophilization improves understanding of how food, drugs and other compounds are preserved in space. This understanding can inform strategies for curating these resources during long-term space travel.

Earth Applications
Eli Lilly-Lyophilization determines different textures created by freeze-drying in the absence of gravity. The experiments can reveal important material properties or purification steps that enhance drug development or other areas of research.

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Operations

Operational Requirements and Protocols

Equipment Required: Microgravity Science Glovebox (MSG), ISS Cameras, ISS Freezers, a custom made Lyo Sample Chamber, and 3 Sample Groups consisting of 2 Sample Trays each. Each Sample Tray includes 6 small vials filled with the test material.
 
Launch Stowage: The project launches to ISS in 3 Sample Groups. Sample Group #1 requires a frozen launch and continuous storage within ISS freezers. The remaining samples (Sample Groups 2 and 3) launch in standard late stow and do not have temperature conditioned stowage during ascent, but are frozen on orbit.
 
On-orbit Deployment: Once on orbit, Sample Group 1 remains frozen until ready for operations inside MSG. Sample Group 2 is transferred from nominal stowage to an ISS freezer until ready for operations inside MSG. Sample Group 3 is transferred to an ISS Freezer where it remains until it is ready to be returned to Earth frozen. The Sample Groups are unstowed from Cold Stowage and deployed for use within MSG as needed. The Lyo Sample Chamber, supporting Lyo equipment and ISS provided cameras are set up within MSG.
 
Use: Once aboard ISS, all Lyophilization Sample Groups are transferred to the ISS Freezer where they freeze and/or are kept frozen. One of those sets remain frozen until return to Earth. The other Sample Groups are transferred to the MSG, 1 group at a time, where they are installed into the Lyo Sample Chamber. The ISS Vacuum Exhaust System (VES) is used to lower the pressure to approximately that of space where the samples are expected to undergo the cryo-desiccation process. A photograph of 1 frozen Sample Vial per scenario are obtained after the lid on the sample vial is actuated.
 
Once complete, the 2 vacuumed groups are photographed and returned to stowage. The remaining frozen group remains frozen through return to earth. All 3 groups are returned to Earth and turned over to the project scientists who perform additional ground observation. The group that was frozen on orbit and returned frozen undergoes vacuum in normal gravity as a comparison to those operated in microgravity on ISS

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Decadal Survey Recommendations

Information Pending

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Results/More Information

Information Pending

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Related Websites

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Imagery