Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

Beyond API Sourcing: Avoiding Supply Disruptions For Small Molecule Drugs

Supply resilience should be assessed across the complete drug product pathway rather than measured by the number of vendors listed in a procurement system.

GUEST COLUMNISTS

Your 7 Decisions To Make Before MES Configuration
Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.
The Orange Book's Blind Spot: Process Stability And Capability
The current system for assuring therapeutic equivalence contains structural blind spots. Companies must evolve rather than merely adding corrective actions.
Are You Falling Behind On Intelligent Pharmaceutical Manufacturing?
With a focus on small molecule drug product manufacture, let's take a closer look at the efficiencies gained through closed-loop control, PAT, digital twins, and more.
DEA Reveals Hidden Costs Of Analytical Validation Guidelines
By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.
Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
CDMO Selection Beyond Capabilities And Price
Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.
August 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.

PHARMA OUTSOURCING WHITE PAPERS

What FDA CRLs Reveal About Method Validation
FDA rejection letters reveal validation failures are structural, not technical. Weak lifecycle oversight, robustness, and documentation continue to delay approvals despite clear guidance.

Vial Fogging: Practical Considerations For Vial Selection
Vial fogging is a common phenomenon observed in lyophilized biologic drug products. This document presents two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.
Process Development For Lyophilized Products
Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.
Enabling Digital Twins With Computational Fluid Dynamics Modeling
Embrace the transformative power of predictive modeling and digital twin technology to optimize bioprocess efficiency, ensure product quality, and drive innovation in biopharmaceutical manufacturing.
Why Get Cleaning Validation Support From The Cleaner Supplier?
Standardize compliant cleaning by integrating risk-based validation, effective residue detection, and science-based limits to reduce cross-contamination and protect product quality.
Patented Process For Intermediates Useful For Etrasimod Arginine
Explore how rethinking the synthetic strategy for Etrasimod can overcome the limitations of legacy routes, enabling more efficient chirality control, improved scalability, and more practical industrial API production.