An article previewing news about a pharmaceutical manufacturer's successful regulatory inspection for oligonucleotide and peptide API production, useful for industry and supply‑chain readers.
Key Takeaways
- Aurisco's Yangzhou site passed a USFDA pre-approval inspection for oligonucleotide and peptide cGMP compliance
- Inspection covered Inclisiran Sodium and included oligonucleotides, GLP-1 peptides, and small molecules
- FDA accepted Aurisco's CAPA plan and complimented the facility, GMP system, and staff knowledge