Page 168 - International Space Station Benefits for Humanity, 3rd edition.

conditions in large, cumbersome bags,” said Principal
Investigator Paul Reichert. A concentrated drug
substance stable at room temperature could be moved
long distances in small containers.
Demonstrating that crystalline suspensions of
monoclonal antibodies are stable, long-term, at room
temperature would eliminate the need for and costs of
refrigerated transportation and enable distribution of the
drug in areas without refrigeration. Additionally, lowering
the costs of production and transport could ultimately
lead to lower costs for patients.
The investigation also could improve the drug
purification process, further lowering production
time and cost. The researchers sent samples of the
monoclonal antibody at different steps in the purification
Protein crystal growth box. process to the space station to see if crystals would
Image credit: ISS National Laboratory form and what level of purity could be achieved.
Preliminary analysis showed clear differences
between the ground and spaceflight samples.
The production of high-quality crystalline suspensions “The samples crystallized in microgravity contain highly
of monoclonal antibodies would not only allow for ordered, uniform crystalline suspensions similar to the
improvements in drug formulation and administration, crystalline suspensions of alpha interferon from our
it could also lead to improvements in drug storage. previous space shuttle experiments,” Reichert said.
“Currently, most monoclonal antibody preparations have “This is exciting because it demonstrates the results
a limited shelf life and must be stored under refrigerated are reproducible under these conditions.”

Ultraviolet imaging of a ground control sample (left) and spaceflight sample (right) from Merck’s investigation,
clearly showing the much more uniform size and distribution of crystals grown in microgravity.
Image credit: Merck

154