02.14.26 -- Outsourced Pharma Best Of January

It is a remarkable twist of industry manipulations, government suasion, and economics. J&J cut a Most Favored Nation deal with the Trump administration that includes lowering prices – via TrumpRx.com – building more in the U.S., and (here’s the twist) investing in the U.S.-based facilities of a Japanese-owned CDMO. Got all that? Chief Editor Louis Garguilo offers analysis.

When earlier this year the Trump administration began waving the specter of tariffs on drug substances and products entering the U.S., the biopharma world held its breath. European countries, as much as even China, felt the lack of oxygen. Would, for example, global sponsors leave European CDMOs to relocate their API production at contractors in the U.S.? Here's what we uncovered.

This segment of the Outsourced Pharma Live event, “Small Molecule Outsourcing: Getting Timelines, Tech Transfer and Analytics Right,” focuses on the key elements of a successful tech transfer for small molecule processes, emphasizing realistic expectations on duration, leveraging CDMO chemistry expertise to refine rather than simply copy the process, and treating the CDMO as an extension of the sponsor’s own team focused on long-term product quality. Featuring panelist Natalie Farris, Executive CMC Consultant at Naltou Pharma CMC Consulting, LLC.

Establishing combination product shelf life requires aligning stability. Holistic, data-driven stability studies ensure product function, safety, and label claims through the entire supply chain.

From the digital infrastructure needed to enable a collaborative approach, to the quality systems and analytical methods, effective tech transfer relies on the careful consideration of a variety of factors.

With these four steps to successful biologic process development, it is possible to mitigate risk, manufacture a high-quality product, and increase the efficiency of your timeline to patients.