Newsletter | November 6, 2026

11.06.26 -- Biotechs Still Underestimate CMC – And Pay The Price

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Can CDMOs Keep Up With the Next Generation of Medicine? Join us November 11, 2026, at 11 AM ET for Outsourcing the Uncharted: Manufacturing Complex and Emerging Therapies, a free expert panel exploring the challenges of outsourcing complex, personalized, and live-cell products—and how innovators are finding specialized CDMO partners to bring breakthrough therapies to patients. Register today!

INDUSTRY INSIGHTS

Our Approach To Regulatory Compliance In China

Leverage proven regulatory expertise and local support to turn China’s rigorous API requirements into a clear, efficient pathway to market success.

Selecting A CDMO Partner For Controlled Substance Oral Solid Dosages

Controlled substance oral solid programs carry unique risks. Evaluating manufacturing partners early across four key dimensions can help reduce them.

Harness High-Quality PBPK Modeling To Enhance Clinical Readiness

Physiologically based pharmacokinetic (PBPK) modeling advancements are helping drug sponsors mitigate risk in preclinical and clinical studies through early identification of poor absorption properties.

FEATURED EDITORIAL

Biotechs Still Underestimate CMC – And Pay The Price

Consultants tell Chief Editor Louis Garguilo that too often those who should know better – from executives to project managers – overestimate their ability to manage CMC activities.

September 2026 — CDMO Opportunities And Threats Report

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

INDUSTRY INSIGHTS CONTINUED

The Value Of In-House Delumping For Homogeneous API Production

API batch homogeneity supports efficient manufacturing. Controlled delumping improves powder flow and chargeability while maintaining particle size integrity and reducing GMP-scale risks.

Leveraging Early Insights To Accelerate The Oral Drug Development Cycle

Consider how the following early development insights can help you navigate complex oral drug development and move your program forward with greater confidence.

Accelerate Your Trials With Smarter Clinical Supply Solutions

Clinical trials require precise packaging, storage, and logistics. Integrated supply strategies boost visibility, reduce risk, ensure compliance, and help teams adapt while maintaining quality.

Development Of A Unique And First-Of-Its-Kind Flow Photo Reactor – CSCPR

A novel circular LED‑based flow photoreactor delivers uniform light intensity, improved energy efficiency, rapid residence times, and scalable throughput for greener photochemical bromination processes.

Open-Label Study Assessing Relative And Absolute Bioavailability

Consistent absorption across different formulations and dietary conditions ensures stable therapeutic exposure. This flexibility simplifies patient dosing schedules and supports manufacturing transitions.

Patient-Centric Formulations In Pediatric Adherence

Improving pediatric adherence requires age-appropriate formulations, taste-masking, and swallowability strategies. Regulatory, clinical, and technological insights help overcome barriers for children.

Segments: Next-Generation Tablet Press Technology

Segments increase press output by up to 25% and cut setup time by 88%. Learn the benefits, drawbacks, and manufacturing needs of this rapidly growing tablet press technology.

How Sandoz Cut Its Supplier Network By 34%: A Consolidation Playbook

Sandoz cut its finished dose form supplier network by 34% in two years. Get the six-step make-vs-buy framework and three-phase consolidation approach that made it possible.

SOLUTIONS

How To Commercialize Small-Volume APIs Without Sacrificing Scale

Solving Oral Solid Dose Challenges Earlier In Development

U.S. Early Development AND HPAPI Manufacturing In Malvern, PA

How To Avoid Costly Handoffs In Drug Product Manufacturing

Blister Solutions

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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