Case Study
Improving Pharmaceutical Manufacturing
ISS study sheds light on factors that lead to protein clumping during drug production
R&D Challenge
Studying the complex motion of proteins in a solution is challenging because the proteins interact with the walls of the container.
Protein-based therapeutics are used to treat and prevent a wide range of conditions, from cancer to HIV, but protein clumping during manufacturing is a problem. If scientists better understood how proteins move in solution and what leads to aggregation, they could explore ways to prevent or reverse it. However, on Earth, the container holding the solution affects how proteins behave.
Industries:
Pharmaceutical, Medical
Strategic Focus Area:
Fundamental Science
Research Area:
Fluid Dynamics
Institution:
Arizona State University and Rensselaer Polytechnic Institute
ISSInternational Space Station NATIONAL LAB SOLUTION AND IMPACTFUL OUTCOME
In microgravityThe condition of perceived weightlessness created when an object is in free fall, for example when an object is in orbital motion. Microgravity alters many observable phenomena within the physical and life sciences, allowing scientists to study things in ways not possible on Earth. The International Space Station provides access to a persistent microgravity environment., researchers can study protein solutions without a container interfering.
Leveraging the ISS, researchers from Arizona State University and Rensselaer Polytechnic Institute did something impossible on Earth—they studied protein solutions without a container. In the absence of gravity, the liquid forms into a floating, self-contained sphere, allowing the team to study protein motion in new ways. The results, published in the journal Fluids, can be used to create models that help scientists better understand the factors that lead to protein clumping.
INVESTIGATORS
Juan Lopez
Professor of Mathematical and Statistical Sciences, Arizona State University
Amir Hirsa
Professor of Mechanical, Aerospace and Nuclear Engineering, Rensselaer Polytechnic Institute
RSD Team - Amir Hirsa center
Shearing (the force produced when fluids slide past each other) can make the protein solution more viscous and turn it into a gel and eventually a solid, and these complications are headaches in pharmaceutical manufacturing. Trying to understand what’s happening on the surface of liquids is becoming more and more relevant to pharmaceutical applications.
– Amir Hirsa, Rensselaer Polytechnic Institute
APPLICATION
The ability to control or reverse protein aggregation during pharmaceutical manufacturing would be invaluable to the medical industry.
Protein-based therapeutics have become critical for the treatment and prevention of many diseases. Hundreds of protein therapeutics are currently on the market, and many more are in clinical trials. The global protein therapeutics market was valued at more than $280 billion in 2020 and is projected to reach more than $565 billion by 2030, according to Allied Market Research. Although there is a significant market for protein-based drugs, there is a significant roadblock for pharmaceutical companies. During manufacturing, proteins can aggregate, or clump together. This lowers the quality of the therapeutic and results in a smaller amount of viable medication or vaccine produced. Finding a way to prevent proteins from clumping would remove the roadblock and revolutionize protein therapeutic manufacturing.
This content is abridged from an article originally published in Upward,
official magazine of the ISS National Lab.
