07.12.25 -- Outsourced Pharma Best Of June

It’s a large and universally recognizable CDMO, so this matters. Swiss-based powerhouse Lonza will increase its focus on biologics and “advanced synthesis” including for antibody-drug conjugates, cell and gene therapies, and mRNA therapeutics. Will other CDMOs follow suit? What's this say about the future of development outsourcing and our industry? 

The art and science of late-stage/commercial formulation, compared to early-phase formulation, is a different ballgame, says Dileep Boinipally, currently utilizing CDMOs to advance a pipeline of oral and injectable candidates. He has a stadium full of advice for readers.

Outsourcing drug development and manufacturing is an attempt at purposeful action in a web of interdependent contingencies. The contingency top-of-mind today is President Trump’s tariff strategy, and global "negotiations" that have ushered in a supply-chain disquietude.

Data-driven modeling techniques can enhance scale-up processes, streamline production, and help companies navigate the complexities of modern drug development with greater precision and reliability.

Insights and case studies demonstrate how a tailored, stepwise testing approach can effectively detect, quantify, and control nitrosamine impurities while maintaining cost efficiency.

The pharmaceutical manufacturing industry has witnessed a significant increase in the number of drug approvals by the FDA over the past few years leading to several packaging innovations.