Newsletter | October 17, 2025

10.17.25 -- The FDA 483 Heard Round The World

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Join 1,000+ pharma, biotech, and drug delivery professionals at the PODD: Partnership Opportunities in Drug Delivery Conference, October 27–28 in Boston. Featuring 10 technology tracks, pharma company spotlights, 1:1 partnering, and more. Attendees will also hear from leaders at companies including AbbVie, Amgen, AstraZeneca, Biogen, Eli Lilly, GSK, Moderna, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, and others. Register at PODDConference.com with code LSL20 for 20% off.

INDUSTRY INSIGHTS

SMB Technology: Optimizing API Purification

Explore how Simulated Moving Bed (SMB) technology can enhance API production while overcoming common misconceptions about chromatographic purification.

Friendshoring: A Strategic Shift In Pharma Supply Chains

To safeguard the consistent delivery of essential therapies to patients around the world, biopharmaceutical companies, alongside their CDMO partners, are rethinking traditional supply models.

FEATURED EDITORIAL

The FDA 483 Heard Round The World

For the first time in more than a decade writing this column, I’ll focus on a specific 483 – actually two – received by a CDMO site. It pains me to do so, for a number of reasons. But the overall industry reaction to this specific FDA issuance compels me to take this on.

Derisking AI Means First Asking: Who Does It Serve?

Artificial intelligence promises productivity boosts and accelerated innovation. But using them invites risk, including accidentally exposing intellectual property.

INDUSTRY INSIGHTS CONTINUED

Quadrupling Inspection Speed With Automated Visual Inspection (AVI)

JHS boosted vaccine vial inspection speed 4x with automated visual inspection, improving accuracy, efficiency, and capacity to 20 million vials annually using the Seidenader CS-40.

Wrap-Around Labeler For Small Vials, Cartridges, And Syringes

Discover a reliable solution for labeling small batches of medical products, including vials, syringes, and cartridges, that fully automatic machines struggle to handle.

SOLUTIONS

OPCU July 2025: Small Molecule Drug Product/Finished Dosage Form

In this presentation, we delve into how expedited review pathways can be strategically used to accelerate development while mitigating CMC risks.

Capabilities Update April 2025: Small Molecule

Leverage expert small molecule solutions from preclinical development to commercial manufacturing, with strengths in large-scale oral solids, advanced formulations, and more.

Manufacturing For Oral Solid Dose Success

Consider using our end-to-end CDMO services for oral solid dose drugs to enable efficient development, manufacturing, and packaging with advanced technologies and global scale.

Solid Form Services

We have defined work flows to assess and select solid forms in a cost and time efficient manner that meets the needs of each individual program.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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