🚨 First-ever product-specific mAb monograph is here!
European Pharmacopoeia just adopted Golimumab (3187 + 3103), 7 new mAb texts, and a dedicated SEC method for recombinant mAbs (2.5.43).
Sub-visible particle testing (2.9.19) fully modernized + 72 revised texts.
Effective:
- Golimumab → 1 Apr 2026
- All others → 1 Jan 2027 (mandatory)
If you’re developing, manufacturing, or selling IgG therapeutics in/to Europe — your analytical methods and AI training data have a hard deadline.
Audit your SEC, particle counting, and stability packages today.
Link: https://www.europeanpharmaceuticalreview.com/news/268787/european-pharmacopoeia-updates-monoclonal-antibody-standards/
Tag someone who needs this wake-up call 🔬⬇️
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