Island Pharmaceuticals Commences Galidesivir GMP Manufacturing
Key points
- GMP manufacture of Galidesivir API started on 1 October at PI Health Sciences
- First 5kg batch targeted for completion by end of October
- Second 5kg batch targeted for completion by late November
- Both batches aim to support Ebola treatment and Marburg NHP study
Full summary
Island Pharmaceuticals Ltd has initiated GMP manufacturing of Galidesivir active pharmaceutical ingredient (API) at PI Health Sciences. The first 5kg batch is targeted for completion by the end of October and will support the company's emergency-use program in Uganda during the Bundibugyo Ebola outbreak. The second 5kg batch, due by late November, will support the broader Ebola strategy and a pivotal Marburg non-human primate study under the FDA Animal Rule. This manufacturing program aims to strengthen Galidesivir's deployment readiness and establish a GMP supply for human Ebola data generation, Marburg development, and potential future government procurement and biodefence opportunities.
Outlook
The manufacturing program is expected to enhance Galidesivir's development readiness and establish a GMP supply for future use.
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