Formulation Insight: the Pembrolizumab Case
What did Merck learn from crystallising pembrolizumab in orbit, and what does the case teach about the business model?
Chapter summary
Merck grew crystalline suspensions of pembrolizumab, the antibody sold as Keytruda, on the ISS and found that microgravity produced a uniform population of crystals about 39 micrometres across, where ground controls produced a mixture of 13 and 102 micrometre particles.
Key takeaways
- 1
Uniform crystals gave less viscous suspensions, which matters for injecting a high dose under the skin rather than by intravenous infusion.
- 2
Merck then applied the insight to ground processes.
- 3
The FDA approved a subcutaneous pembrolizumab product, Keytruda Qlex, on 19 September 2025; it is made on Earth.
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