A roundup of manufacturing news from Novartis and Novo Nordisk/Ginkgo. Highlights below. 

* Novartis To Implement Mfg Changes for Breast Cancer Drug Candidate due to Nitrosamine Impurities 
* Novo Nordisk, Ginkgo Bioworks in Mfg Pact 

---

Novartis To Implement Mfg Changes for Breast Cancer Drug Candidate due to Nitrosamine Impurities 
Novartis reports that enrollment of new patients in clinical trials for Kisqali (ribociclib) for treating early breast cancer (eBC) has been paused due to regulatory guidance on intake limits for nitrosamines in medications. 

The company says that this does not impact patient use or commercial supply of Kisqali in its approved indication of metastatic breast cancer.  

The company says it is implementing manufacturing adjustments to ensure alignment with the latest regulatory standards for the product in eBC studies by the end of the second quarter of 2024. 

Source: Novartis 

---

Novo Nordisk, Ginkgo Bioworks in Mfg Pact 
Novo Nordisk and Ginkgo Bioworks, a Boston-based biotechnology company specializing in cell engineering for industrial applications, have expanded their strategic partnership under a framework agreement that initially is contemplated to run over five years.   

Novo Nordisk and Ginkgo have created a flexible and scalable new model for their R&D partnership that seeks to improve the manufacturing of Novo Nordisk’s medicines for serious chronic diseases, including diabetes and obesity medications. The companies also plan to collaborate on several early pipeline projects, further technology exploration, and engineering of scalable manufacturing across Novo Nordisk’s portfolio.  

Source: Ginkgo Bioworks