09.12.26 -- Outsourced Pharma Newsletter - Best Of August

A lower-court ruling does not make a victory. But it adds a little sanity to this melodrama. On August 7, a U.S. District Judge did something that has been surprisingly rare in the long-running WuXi AppTec/BIOSECURE Act saga: He looked at the U.S. government's case for labeling WuXi a “Chinese military company” and decided the government had not shown enough evidence. Analysis from Chief Editor Louis Garguilo.

An AI-driven CDMO search tool is returning insights into how today’s sponsors select external supply-chain partners. Aptly dubbed CDMO Signal, the application aggregates FDA inspection data, clinical trial records, SEC filings, and various other attributes across over 150 CDMOs. We've noticed at least three intriguing search threads originating from this newly created search tool.

Asset development and outsourcing strategies can be intriguing, and full of global connections. Those attributes surface immediately in a conversation with Hyung Heon Kim, Chief Executive Officer and President, MetaVia, a Cambridge, Mass.-based biotech. The company reformed recently, but has roots back to 90 years of South Korean pharma history. Tracing the CDMO relationship MetaVia has is also part of the organization’s history. “Ours is a fun journey to tell,” says Kim. Fun, informative, and enlightening.

Build a strong foundation in solid form science — especially polymorphism — to reduce risk, control variability, and accelerate your path from development to reliable, cost-effective manufacturing.

The support of an experienced CDMO is critical to overcoming complexity when working with highly potent APIs and when solving solubility challenges.

Spray drying enables stable, scalable dry‑powder nasal biologics, improving shelf life, particle control, and targeted delivery for peptides, proteins, vaccines, and oligonucleotides.