Newsletter | December 15, 2024

12.15.24 -- Is The BIOSECURE Act The First Real Step Toward Reshoring?

FEATURED EDITORIAL

Defining When To Implement Technologies To Support Commercial Growth

Technology decisions must be understood in the context of your business strategy and projected milestones. With a framework in place, you can define what tech solution you need and when you need it.

Is The BIOSECURE Act The First Real Step Toward Reshoring?

The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?

Computer Systems Validation Pitfalls, Part 3: Execution Inconsistencies

The authors continue their article series on computer systems validation pitfalls by sharing a common mistake made by inexperienced senior QA personnel and more.

INDUSTRY INSIGHTS

Comparing Molecular Methods vs. In Vitro Testing for Virus Detection

Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.

Optimize Your RFP To Ensure Successful Biologic Development

Creating a thorough, comprehensive RFP will help a CDMO partner lay the foundation for a productive partnership, fulfill your goals, and help ensure future market success for your therapeutic.

Sterilizing Grade Filter Performance With Biologic Drugs

Examine the throughput performance of sterilizing grade filters across moderate-to-high concentrations of mAbs and immunoglobulins as well as how filter selection can impact your process.

NEWS HEADLINES

Accord BioPharma Announces Agreement By Intas Pharmaceuticals, Ltd. To Acquire UDENYCA® (pegfilgrastim-cbqv) Business From Coherus BioSciences, Inc., Unlocking Potential For Continued U.S. Growth

U.S. FDA Approves Biocon Biologics' YESINTEK™, Bmab 1200 Biosimilar To J&J's Stelara® (Ustekinumab)

First Shipment Of Henlius Trastuzumab To U.S.

SOLUTIONS

Valor Glass: The Future Of Glass Packaging Is Here