Newsletter | June 3, 2026

06.03.26 -- BIOSECURE Act And The 8 Supply-Chain Lessons Sponsors Can't Ignore

SPONSOR

Join editor Jeff Buguliskis on June 4, 2026, at 11 a.m. ET for Outsourced Pharma Live: Beyond Data Packages: Derisking Tech Transfer To CDMOs. Industry experts will explore how sponsors can better prepare for successful tech transfers by addressing common challenges including incomplete data packages, equipment differences, method variability, global standards, and CMC alignment. Learn strategies using smarter documentation, DOE, and in silico modeling to improve right-first-time transfer success. Register now

INDUSTRY INSIGHTS

Accelerated Development Of Solid Oral Dosage Formulation

View how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.

Tablet Edge Erosion – Solutions For Friability

Addressing tablet edge erosion and friability involves adjusting formulation, tablet design, tooling, press setup, and operation speed to improve tablet robustness and reduce weight loss.

Considerations When Outsourcing Your Packaging Operations

Explore the key to maintaining and enhancing existing and new partnerships as well as how outsourcing one crucial aspect of bringing products to market can benefit overall supply chain optimization.

FEATURED EDITORIAL

BIOSECURE Act And The 8 Supply-Chain Lessons Sponsors Can't Ignore

For sponsors rethinking China-exposed supply chains, BIOSECURE is less a warning label than a stress test for redundancy, oversight, data control, and operational resilience.

Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24

FDA's accelerated approval guidance kicked off a rebalancing of new drug approval pathways. Since its 2024 release, the agency has been building on it in a few key areas.

INDUSTRY INSIGHTS CONTINUED

From Brick Dust To Breakthrough: The Power Of Enabled Formulation

Enabled formulation strategies transform poorly soluble, highly lipophilic molecules into viable oral products by improving exposure, reducing burden, and ensuring manufacturable pathways.

Maximizing Drug Formulations For First-In-Human Trials

Discover how drug formulation strategies in first-in-human trials impact safety, dosing, and regulatory success, with case studies highlighting integrated development and manufacturing approaches.

New Technologies To Improve Solubility Of Brick Dust Compounds

David Lyon, Ph.D., and Molly Adam answer attendee questions from a recent webinar about three enabling technologies designed to improve drug solubility in organic solvents for spray drying.

Strategies For Enhancing Bioavailability Of Poorly Soluble Compounds

See key strategies for enhancing bioavailability of poorly soluble drug compounds, including spray drying, particle size reduction, and lipid-based formulations supported by solid-state analysis.

SOLUTIONS

Custom API Manufacturing For Small Molecule And High‑Potency Programs

Scalable Solutions For High Potent OSD Manufacturing

State-Of-The-Art Drug Product Manufacturing Capabilities

Solving Complex Formulation Challenges From Coast To Coast

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. 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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