Best of March: Top 5 Insights in Outsourced Drug Development and Manufacturing

#1 - BIO Expels WuXi, Agrees With U.S. Government

“BIO is taking steps now to separate from WuXi-AppTec regarding membership in the organization," says Biotechnology Innovation Organization President & CEO John F. Crowley. But to Chief Editor Louis Garguilo, this seems like a strange company to target.

#2 - CDMO Opportunities And Threats Report — February 2024

The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

#3 - Trends In FDA FY2023 Inspection-Based Warning Letters

The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23) and 94 of them were based on an on-site inspection of the company. View an analysis of trends and observations from the inspection-based letters.

#4 - Consolidating The Supply Chain For mRNA

Learn about the first end-to-end cGMP facility that was developed for mRNA manufacturing to address the shortage of CDMOs and the inadequate and inefficient supply chain options for sourcing GMP mRNA.

#5 - 8 Key Takeaways Of The Proposed FDA Modernization Act 3.0

The proposed legislation aims to reduce and replace the use of animals in nonclinical research, improve predictivity of nonclinical testing, and potentially reduce drug development times. This article shares an overview.